News

Study of Prolia (Amgen/GSK) plus teriparatide shows significant benefits in Osteoporosis

A randomised, controlled trial of postmenopausal women with Osteoporosis shows that teriparatide and Prolia (denosumab), from Amgen/GSK, increased bone mineral densification (BMD) better than previously reported with any available treatment. Ninety four postmenopausal women were assigned in a 1:1:1 ratio to receive 20 ug teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, ...

FDA approves Ilaris (Novartis) for treatment of Systemic Juvenile Idiopathic Arthritis

Novartis announced that the FDA has on 10 May 2013 approved Ilaris (canakinumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.

SJIA ...

PALACE 4 study confirms success of apremilast (Celgene) in treatment of Psoriaric Arthritis

Celgene International Sàrl,has announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4 study. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis. This is ...

CHMP rejects Xeljanz (Pfizer) as a treatment for Rheumatoid Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active Rheumatoid Arthritis. The CHMP is of the opinion that Xeljanz does not demonstrate a favorable risk:benefit profile at this time and recommended against marketing authorization.

...

EMA Pharmacovigilance Risk Assessment Committee recommends restrictions on Protelos (Servier) as a treatment for Osteoporosis

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended restrictions in the use of Protelos/Osseor (strontium ranelate) from Servier, following the evaluation of data showing an increased risk of heart problems, including heart attacks. It will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.

Study shows Ostinol (ZyCal Bioceuticals) improves pain and stiffness in Osteoarthritis

Results of the first double-blind, placebo-controlled study evaluating the benefits of Ostinol (cyplexinol), from ZyCal Bioceuticals, in alleviating symptoms of Osteoarthritis shows that this nutritional supplement decreases pain and stiffness, and offers an increase in quality of life as compared to placebo. Cyplexinol is a biologically active protein complex consisting of bone morphogenetic proteins which stimulate bone and cartilage growth ...

Fostamatinib (AstraZeneca) mixed results in OSKIRA-1 trial for RA

AstraZeneca has announced top-line results of OSKIRA-1, a Phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for Rheumatoid Arthritis (RA).

OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified ...

Phase II study of Xiaflex (Auxilium Pharma) shows benefits for patients with Adhesive Capsulitis

Auxilium Pharmaceuticals has announced positive data for Xiaflex (clostridial collagenase injection), from Auxilium Pharma, for the treatment of adults with Adhesive Capsulitis (AC), or Frozen Shoulder Syndrome. The Phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of Xiaflex for the treatment of Stage 2 unilateral idiopathic AC in comparison to an exercise-only ...

Study shows RoActemra/Actemra (Genetech/Roche) superior to Humira in achieving remission in Rheumatoid Arthritis patients

New data confirms RoActemra/Actemra (tocilizumab), from Genetech/Roche, is superior to Humira (adalimumab) in achieving disease remission in Rheumatoid Arthritis patients when either is used without methotrexate (MTX). Data shows that over 50% of RA patients can achieve low disease activity or remission with RoActemra/Actemra, compared to under 20% of those treated with the most widely prescribed anti-TNF Humira when neither ...

EU approves GelrinC (Regentis Biomaterials) for Cartilage Repair

Regentis Biomaterials has received European CE Mark approval for its GelrinC biodegradable implant, for Cartilage Repair. GelrinC is suitable for patients with traumatic knee injuries. It is inserted as a liquid to fill any shape of cartilage defect and it is then converted into a solid through exposure to ultra-violet light. GelrinC's matrix of synthetic polyethylene glycol diacrylate and denatured ...

EU approves Ilaris (Novartis) to treat Gouty Arthritis

Novartis has announced that the European Commission has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered ...

UCB files Cimzia at FDA and EMA for treatment of axial Spondyloarthritis

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active axial Spondyloarthritis (axSpA)

UCB files Cimzia for Psoriatic Arthritis at FDA and EMA

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active Psoriatic Arthritis.

SOBI and Savient Pharma to co -promote Kineret in USA

Sobi and Savient Pharmaceuticals, Inc. have entered into an agreement for the co-promotion of Kineret (anakinra) in the U.S. Kineret, a recombinant IL-1 receptor antagonist, is a treatment for rheumatoid arthritis (RA) and indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active RA in patients 18 years of ...

EU approves ApiFix AIS System (ApiFix) for Adolescent Idiopathic Scoliosis

ApiFix has received CE Mark approval for its ApiFix AIS correction system, a minimally invasive treatment system for Adolescent Idiopathic Scoliosis (AIS). ApiFix also reports that it has successfully completed a European pilot clinical trial with positive results.

In the ApiFix system, a small implant is attached to the center of the main spinal curvature using only two screws, resulting ...

NICE does not recommend Krystexxa (Savient Pharma) for treatment of severe Gout

The National Institute for Health and Clinical Excellence (NICE) has opened a consultation on the use of Krystexxa (peglioticase) from Savient Pharma, in treating severe debilitating chronic tophaceous Gout in adults. Draft guidance does not recommend the drug for this use. NICE's independent appraisal committee has decided that the drug effectively lowers the level of uric acid in the ...

Positive results in Phase III trial of Xeljanz (Pfizer) in patients with Rheumatoid Arthritis

A Phase III clinical trial demonstrates that Xeljanz (tofacitinib), from Pfizer, improves disease activity and inhibits progression of joint damage in Rheumatoid Arthritis (RA) patients who did not respond to methotrexate (MTX). In this 24-month, double-blind, placebo-controlled study, 797 participants were randomized to receive 5mg of tofacitinib (n=321); 10 mg of tofacitinib (n=316) or placebo. Results from a 12-month interim ...

CHMP recommends extension of indication of Humira(AbbVie) in JIA

The CHMP recommends that Humira (adalimumab) from AbbVie, in combination with methotrexate is to be indicated for the treatment of active Polyarticular Juvenile Idiopathic Arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to ...

FDA approves the iASSIST Knee (Zimmer) for Knee Replacement surgery

The FDA has given 510(k) clearance to the iASSIST Knee, from Zimmer, which is a personalized guidance system for Knee Replacement procedures. The technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display.

The disposable pods are manipulated within the surgical field with ...

CHMP recommends Ilaris (Novartis) for treatment of Acute Gouty Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of llaris (canakinumab, ACZ885) from Novartis, in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.

Ilaris is the only available ...

Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure comprised of questions about knee swelling, clicking, catching ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

FDA rejects Ampligen (Hemispherx) as a treatment for Chronic Fatigue Syndrome

The FDA Arthritis Advisory Committee rejected the re-application by Hemispherx for Ampligen (rinatatolimod) as a treatment for Chronic Fatigue Syndrome. The Committee voted 8 votes to 5 votes to reject the drug. The FDA was unimpressed with the clinical trial evidence as to efficacy, but accepted that the drug was safe. There are currently no approved treatments for Chronic Fatigue ...

Results of Phase III studies show substantial benefits of ACZ 885 (Novartis) in patients with Juvenile Idiopathic Arthritis

Results of two Phase III trials show ACZ 885 (canakinumab), from Novartis, provided substantial symptom relief in young patients with systemic Juvenile Idiopathic Arthritis (SJIA). In addition, ACZ 885 delayed disease flare recurrence and allowed patients to substantially reduce or discontinue use of corticosteroids.

In beta-SPECIFIC 1 (trial-1), 84% of SJIA patients treated with ACZ 885 experienced at least a ...

Antares Pharma files Otrexup at FDA for Rheumatoid Arthritis

Antares Pharma has submitted a New Drug Application (NDA) to the FDA for Otrexup, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology. Otrexup was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis....

Phase IIb report of fostamatinib (AstraZeneca) OSKIRA-4 trial for RA

AstraZeneca announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA). OSKIRA-4 was a six month study evaluating improvements in signs and symptoms of RA in 280 patients who had never previously used a disease-modifying anti-rheumatic ...

FDA approves NavioPFS orthopedic surgical system (Blue Belt Technologies) for Knee Replacement

Blue Belt Technologies has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system. The clearance is for Unicondylar Knee Replacement, commonly known as partial Knee Replacement. The NavioPFS system incorporates technology to provide precision information to surgeons via smart instrumentation with robotic control. It delivers intra-operative navigation and 3D visualization during the surgery based on a ...

Stelara (J&J Janssen Cilag/Janssen Biotech) filed with FDA and EMA to treat adults with active Psoriatic Arthritis

Janssen Biotech and J&J Janssen Cilag have submitted a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation to the EMA requesting approval of Stelara (ustekinumab) for the treatment of adult patients with active Psoriatic Arthritis. These applications are supported by findings from Phase III multicenter, randomised, double-blind, trials of ustekinumab PSUMMIT I and PSUMMIT II, ...

Sobi files Kineret at EMA for CAPS treatment

Sobi (Swedish Orphan Biovitrium)) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of Cryopyrin Associated Periodic Syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe ...

FDA approves Xeljanz (Pfizer) to treat Rheumatoid Arthritis

The FDA has approved Xeljanz (tofacitinib) , from Pfizer,on 6 November 2012, to treat adults with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active RA. In all of ...

CHMP recommends Krystexxa (Savient Pharma) for treatment of Gout

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Krystexxa, 8 mg/ml, concentrate from Savient Pharma, for solution for infusion intended for the treatment of severe debilitating chronic tophaceous Gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric ...

FDA approve Coflex (Paradigm Spinal) to treat moderate to severe Stenosis

The FDA has granted a Premarket Approval Order for Coflex, a motion preserving interlaminar stabilization device from Paradigm Spine, for the treatment of moderate To severe Stenosis with or without back pain. The approval is based on comprehensive Level 1 comparative effectiveness study for the treatment of spinal Stenosis. The six year clinical trial demonstrates Coflex provides better or equivalent ...

Phase II success for odanacatib (Merck Inc.) for Post Menopausal Osteoporosis

Merck Inc., has announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of Osteoporosis in post-menopausal women. The results were presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo) significantly increased Bone ...

EU approves subcutaneous formulation of Orencia (BMS) for moderate to severe Rheumatoid Arthritis

The European Commission has granted marketing authorization for the subcutaneous formulation of Orencia (abatacept), from BMS, in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active Rheumatoid Arthritis (RA). The drug was previously approved for intravenous delivery so this extends the choice of administration route for patients and doctors. Approval of the subcutaneous formulation of ...

FDA expand approval for Healicoil PK (Smith&Nephew) for Joint Repairs

Smith & Nephew has received FDA clearance to expand the indications within the hip for its Healicoil PK suture anchor and Osteoraptor suture anchor. Indications for the Healicoil PK Suture Anchor have been expanded to include abductor repair while those for the Osteoraptor Suture Anchor now include labral reconstruction. Healicoil PK suture anchor differs from conventional solid-core implants by eliminating ...

FDA approves Prolia(Amgen) for treatment of Male Osteoporosis

Amgen announced the FDA has approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with Osteoporosis at high risk for fracture. Prolia, the first FDA approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. According to the National Osteoporosis Foundation,two million men in the U.S. ...

Janssen Biotech submit application to FDA for Simponi as treatment for adults with active Rheumatoid Arthritis

Janssen Biotech has submitted a Biologics License Application (BLA) to the FDA requesting expanded approval for an intravenously delivered form of Simponi (golimumab) for the treatment of adults with moderately to severely active Rheumatoid Arthritis. This is supported by findings from the Phase III trial of Simponi, the GO-FURTHER study, which evaluated the safety and efficacy of intravenously administered Simponi, ...

FDA approves Lospa Knee System (Corentec America) for Knee Replacement Surgery

The FDA has given clearance to market the Lospa Knee System, from Corentec America in the United States. The innovative Knee Joint Replacement System is available and offers an anatomically featured shape for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This ensures successful patient outcomes with natural knee range of motion and ...

Legion HK Hinge Knee implant launched by Smith & Nephew in US and Canada

Smith & Nephew the global medical technology business, announced the launch of its Legion HK Hinge Knee implant to surgeons in the US and Canada. As the first hinged knee to be designed using normal knee kinematics, the implant provides a new option for those patients facing difficult primary or revision knee surgery....

Apremilast (Celgene) success in PALACE 2 & 3 trials for Psoriatic Arthritis

Celgene International Sàrl, a subsidiary of Celgene Corporation announced that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving apremilast 20 mg and 30 mg BID in both the PALACE-2 & 3 phase III studies. Positive PALACE-1 data was previously reported.

PALACE-2 & 3 are the second and third of three pivotal ...

Sirukumab (Janssen/GSK) to enter Phase III for RA

Janssen Biologics (Ireland) and GSK entered into a co-development and co-commercialisation license agreement with respect to sirukumab (CNTO 136),a human anti-interleukin (IL)-6 monoclonal antibody for Rheumatoid Arthritis.

Two studies comprise the Phase III program and are : SIRROUND-T, A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor ...

Study shows almost no difference in mortality with TNF drugs for Rheumatoid Arthritis

A follow-up study of Swedish patients with Rheumatoid Arthritis taking TNF inhibitors Humira, Enbrel and Remicade reveals that there is no significant difference in the rates of death among patients. The study followed 1609 patients between 2003 and 2008. The results have been published in Arthritis and Rheumatism. "While we found no statistically significant difference in mortality rates across the ...

FDA requires more data for Arcalyst (Regeneron) for Gout Flares treatment

The FDA has again issued a Complete Response Letter for the supplemental Biologics License Application for Arcalyst (rilonacept) from Regeneron for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The agency has requested additional clinical data, as well as additional chemistry, manufacturing and controls information related to a proposed new dosage form....

ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 ...

ORAL Start trial success for tofacitinib (Pfizer) in RA

ORAL Start is an ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active Rheumatoid Arthritis (RA), randomized to receive tofacitinib 5 or 10 mg twice-daily (BID) from Pfizer, as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown ...

South Korea approves first biosimilar Remsima from Celltrion to compete with Remicade

South Korea has granted the first approval worldwide to a biosimilar version of Johnson & Remicade (infliximab) from Johnson & Johnson/Merck Inc. ).The regulatory clearance is for Remsima (CT-P13) from Celltrion and is also the first to be given anywhere to a biosimilar monoclonal antibody.Remsima may also be launched by the end of the year in a number of Asian ...

Phase III trial for Odanacitib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Apremilast (Celgene) success in Phase III study of Psoriatic Arthritis

Top-line results are reported by Celgene from the PALACE-1 study, the first of three pivotal Phase III, randomized, placebo-controlled studies evaluating apremilast, the novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis who had received an oral disease-modifying antirheumatic drug biologic therapy or had failed on an anti-tumor necrosis factor agent. Apremilast treatment in this study ...

Phase III trial for Odanacatib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Stryker withdraws Rejuvenate Modular and ABG II neck stem Hip Replacements

Patients have encountered Stryker hip replacement problems and developed symptoms similar to those seen in metal-on-metal hip replacement devices. Stryker Orthopaedics will voluntarily remove Rejuvenate and ABG II modular-neck stem hip replacemenrs and terminate global distribution of these products. The decision comes after continued post-market surveillance. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to ...

Positive data in study of Krystexxa (Savient Pharma) in patients with Gout

New results show that adult patients with refractory chronic Gout (RCG) treated bi-weekly with Krystexxa (pegloticase), from Savient Pharma, experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies. Results at week 25 demonstrated that mean improvements from baseline ...

Horizon Pharma licenses Latin American rights to Duexis to Grunenthal

Horizon Pharma has exclusively licensed Duexis (ibuprofen and famotidine) to Grunenthal for commercialisation in Latin America. Duexis is a single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine. It is indicated in the US for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, in ...

Treatment with anti-TNFs can increase the risk of Herpes Zoster by up to 75 percent

Patients with inflammatory rheumatic diseases treated with anti-TNFs such as Remicade have a 75% greater risk of developing Herpes Zoster, or shingles, than patients treated with traditional disease modifying anti-rheumatic drugs (DMARDs), according to a meta-analysis presented at the Annual Congress of the European League Against Rheumatism. The study is based on a literature search in Medline, Embase, the Cochrane ...

ACZ 885 from Novartis success in Systemic Juvenile Idiopathic Arthritis

New data from a trial with ACZ 885 (canakinumab) was announced by Novartis. A pivotal Phase III study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) . SJIA is a rare and serious autoiflammatory disease that usually start in childhood.The study met its primary endpoint, and the results will be presented on 7 June at the annual congress of the ...

Actemra (Genentech/Roche) success in ADACTA study in RA

Data from the ADACTA study showed that adult Rheumatoid Arthritis (RA) patients who received Actemra (tocilizumab) from Genentech/Roche as single-agent therapy (without other DMARDs) experienced a significantly greater improvement in disease activity (DAS28 score reduction) after 24 weeks compared to patients who received adalimumab as single-agent therapy. The results of ADACTA will be presented on Friday at the annual European ...

Results of AMPLE study of Orencia(BMS) presented at EULAR

Results are announced at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology of AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate), a head-to-head clinical trial of 646 patients comparing the subcutaneous (SC) formulation of Orencia (abatacept) from BMS vs. Humira (adalimumab), each on a background of methotrexate (MTX), in biologic naïve ...

Positive Phase III data for Krystexxa (Savient Pharma) in Gout patients with chronic Kidney Disease

New results show that patients with refractory chronic Gout (RCG) who also suffer from chronic Kidney Disease (CKD) responded to treatment with Krystexxa (pegloticase), from Savient Pharma, regardless of baseline CKD stage. This post-hoc analysis evaluated more than 200 patients with CKD stages one through four who were randomized to receive treatment with Krystexxa 8 mg every other week, 8 ...

Positive results for Humira (Abbott) in one of longest trials in patients with Rheumatoid Arthritis

Abbott announced results from two long-term, open-label studies evaluating Humira (adalimumab) treatment for up to 10 years in patients with long-standing, moderate-to-severe Rheumatoid Arthritis (RA). These 10-year studies, DE019 and DE020, are among the longest, open-label trials in RA. In both studies, patients were assessed for improvements in signs and symptoms of the disease, such as joint pain, swelling and ...

Phase III PSUMMIT 1 study of Stelara (J&J Janssen Cilag) for patients with Active Psoriatic Arthritis reaches primary endpoint

Data from the 615-patient Phase III PSUMMIT 1 trial showed patients with Active Psoriatic Arthritis receiving Stelara (ustekinumab), from J&J Janssen Cilag, achieved the primary endpoint of the study, a significant reduction in Arthritis signs and symptoms at week 24. At the primary endpoint, 42 percent and 50 percent of patients receiving Stelara (45 mg and 90 mg, respectively) achieved ...

Phase III GO-FURTHER trial shows Simponi (Janssen Biotech) significantly improved Rheumatoid Arthritis

Phase III study findings show that patients with active moderate to severe Rheumatoid Arthritis (RA) who received Simponi (golimumab), from Janssen Biotech, demonstrated improvements in signs and symptoms and disease activity. Investigators reported nearly 60 percent of patients receiving Simponi achieved a 20 percent improvement in arthritis signs and symptoms at week 14, the study's primary endpoint, and more than ...

FDA Advisory Committee rejects Arcalyst(Regeneron) for treatment of Gout Flares

The FDA Arthritis Advisory Committee rejected Arcalyst (rilonacept) from Regeneron , voting 11-0 that the data submitted had failed to support the approval of a subcutaneous once weekly dosage of Arcalyst to prevent Gout Flares. The Advisory Committee noted the small numbers of patients in the studies and the absence of long term and safety data which did not exist ...

FDA Advisory Committee recommends tofacitinib (Pfizer) for Rheumatoid Arthritis

The Arthritis Advisory Committee to the FDA voted 8-2 to recommend approval of the investigational agent tofacitinib from Pfizer for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act action date in August 2012. If approved by the FDA, tofacitinib would be the first new ...

NICE rejects Benlysta (GSK) for SLE in final guidance

The health technology appraisal body in England and Wales, NICE, has in its final guidance rejected Benlysta ((belimumab ) from GSK/Human Genoma Sciences for Systemic Lupus Erythematosus (SLE) treatment. The decision was criticised by GSK, which said the UK's failure to adopt innovative medicines is a continuing systemic problem....

UP 446 botanical extract (Unigen) reduces pain scores in Osteoarthritis

In a randomised, double blind, placebo study, 60 people aged between 45 and 75 years were given, in the first group, placebo,in the second and third groups given 250 mg and 500mg per day of the botanical extract UP 446 from Unigen and in the fourth group were given 200 mg per day of celecoxib for 90 days. Results showed ...

Positive results in Phase IIb study of CG100649 (CrystalGenomics) for Osteoarthritis

A Phase IIb study of the CG100649, from CrystalGenomics, shows the candidate drug for Osteoarthritis met its primary and secondary endpoints in an evaluation of the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex (celecoxib) (200 mg per day) over a 4 week treatment period. Anti-arthritic efficacy was evaluated using the ...

MHRA recalls MITCH TRH hip replacements

The MHRA has advised surgeons to stop using the MITCH TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics, and to closely monitor patients who already have them. The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either ...

CDP7851/AMG 785 (UCB/Amgen) enters Phase III for Osteoporosis

UCB and Amgen have announced the start of their sclerostin antibody (CDP7851/AMG 785) Phase III clinical trial program for the treatment of Post Menopausal Osteoporosis. The Phase III program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 ...

Results show Protelos (Servier) slows progression of Osteoarthritis

New results of a Phase III study show that Protelos (strontium ranelate), from Servier, show the drug has beneficial effects for Osteoarthritis as well as offering beneficial effects on pain, function, and mobility. In the study, 1,683 patients with knee Osteoarthritis received either Protelos 2g/day, 1g/day or placebo. The primary endpoint was the measurement of narrowing of the medial-tibio femoral ...

AbbVie is the new Abbott research based pharma company

Abbott Labs has announced that AbbVie [pronounced Abb-vee] will be the name of the new, independent research-based pharmaceutical company it expects to launch by the end of 2012. In October 2011, Abbott announced it would separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. AbbVie, the research-based pharmaceutical company, will include Abbott's ...

FDA approves generic Bonviva (Roche)

The FDA has approved the first generic versions of Boniva (ibandronic acid), from Roche, a once-monthly product to treat or prevent Osteoporosis in women after menopause. The manufacturers that have gained FDA approval for generic 150 milligram tablets are Apotex, Orchid Healthcare, and Mylan. The once-monthly Bonviva branded 150 mg tablet was originally approved by the FDA in March 2005....

Protelos(Servier) indication for Osteoporosis to be updated by EMA

The EMA still views Protelos/Osseor (strontium ranelate) from Servier Labs as an "important treatment" for women with Osteoporosis and its benefit: risk profile remains favourable, but it is no longer to be recommended for certain patients,and warnings on serious skin reaction will be updated. Prescribers should no longer prescribe the treatment to patients with current venous thromboembolism (VTE) or a ...

Posiive Phase III results for OMS302 (Omeros Corp) in Cataract Surgery

A Phase III clinical trial evaluated OMS302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery has met its primary endpoint by demonstrating statistically significant maintenance of intraoperative mydriasis (pupil dilation). OMS302 also demonstrated statistical superiority (p<0.00001) over placebo in reduction of pain in the early postoperative period. The trial enrolled 405 patients randomized 1:1 to receive either OMS302 ...

Aegerion Pharma files lomitapide for HoFH at EMA and FDA

Aegerion Pharmaceuticals a company focused on the development of novel therapeutics to treat severe lipid disorders, has announced that it has submitted a New Drug Application (NDA) to the FDA, and a Marketing Authorization Application (MAA) to the EMA seeking approval of its lead investigational therapeutic, lomitapide, as an adjunct to a low fat diet and other lipid-lowering therapies to ...

Phase III trial begins of ARX-01 System (AcelRx Pharmaceuticals) for treatment of Post-Operative Pain

Dosing has begun in a Phase III study for ARX-01, the Sufentanil NanoTab PCA System from AcelRx Pharmaceuticals. ARX-01 is a pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. This first ARX-01 Phase III study is a randomized, double-blind, placebo-controlled efficacy and safety trial in adults following open abdominal ...

MHRA issues guidance on all metal hip replacement

The MHRA in the UK has issued guidance on hip implants (large head implants) requiring blood tests to check for metal ions and to require a MRI if patients have raised metal levels due to breakup and consquent debris from all metal hips. The MHRA estimates that around 49 000 patients out of 69 000 all metal hip patients fall ...

C-EARLY Phase III study of Cimzia (UCB) begins for Rheumatoid Arthritis patients

A Phase III study to evaluate the efficacy and safety of Cimzia (certolizumab pegol), from UCB, in combination with methotrexate (MTX) for adults with early moderate to severe Rheumatoid Arthritis, has begun. The C-EARLY study also aims to assess whether the frequency of Cimzia administration can be reduced after sustained low disease activity has been achieved. C-EARLY will evaluate patients ...

NICE updates advice allowing earlier use of RoActemra/Actemra (Roche) for Rheumatoid Arthritis

According to NICE, patients with Rheumatoid Arthritis can now be offered RoActemra/Actemra (tocilizumab), from Roche, alongside other treatment options at an earlier stage. Under this updated guidance, RoActemra/Actemra is now recommended, in combination with methotrexate, for treating Rheumatoid Arthritis if treatment with disease-modifying anti-rheumatic drugs (DMARDS) has failed, and provided that the manufacturer offers the drug with the discount agreed ...

Cimzia (UCB) Phase III success in Psoriatic Arthritis

Top-line results were reported from the RAPID-PsA phase III study evaluating the efficacy and safety of Cimzia (certolizumab pegol) from UCB, in patients with adult onset active Psoriatic Arthritis and demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of Psoriatic Arthritis. Initial analyses suggest that no new safety signals were observed in ...

FDA to review tofacitinib(Pfizer) for Rheumatoid Arthritis in August 2012

The FDA has accepted for review the oral JAK inhibitor tofacitinib (CP-690,550) from Pfizer as a treatment for adults with moderately to severely active Rheumatoid Arthritis.The review is expected to take place in August 2012. The drug also is under review by the European Medicines Agency for the same indication. The submissions are based on the results of the ORAL ...

European decentralised approval concluded for Steovess (Takeda) for Osteoporosis

Takeda Pharmaceuticals International GmbH announced that the European decentralised procedure was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of Post-menopausal Osteoporosis. The Company submitted its application for marketing authorization in multiple countries through the DCP on 17 September 2010, with the United Kingdom (MHRA) serving as its Reference Member State ...

NICE recommends RoActemra(Roche) for Systemic Idiopathic Juvenile Arthritis

The National Institute for Health and Clinical Excellence (NICE) has published final guidance that recommends RoActemra (tocilizumab)from Roche for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA) for use in patients aged two and older who have sJIA in whom specific previous treatments have not produced an adequate response subject to Roche making the drug available with a discount as ...

FDA accepts filing of Lodotra (Horizon Pharma) for Rheumatoid Arthritis

The FDA has accepted a new drug application for Lodotra, from Horizon Pharma, being a modified delayed-release formulation of low-dose prednisone, as a treatment for Rheumatoid Arthritis in adults. The FDA has established 26 July 2012 as the Prescription Drug User Fee Act action date. Lodotra is approved for marketing by Merck-Serono and MundiPharma in 16 European countries, for Rheumatoid ...

Arcalyst (Regeneron) is filed at FDA for Gout Flares

The FDA has accepted the supplemental Biologics License Application for Arcalyst (rilonacept) injection from Renereron, for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The FDA plans to review the application on July 30 2012. Arcalyst is already available in the USA and EU for treatmentof rare genetic cryopyrin-associated periodic syndromes (CAPS). Arcalyst is ...

Tofacitinib (Pfizer) is filed at EMA for Rheumatoid Arthritis

A market authorisation application for tofacitinib (CP-690,550),a novel, oral JAK inhibitor from Pfizer has been validated by the European Medicines Agency (EMA) for for the treatment of moderate-to-severe active Rheumatoid Arthritis. Validation means that the EMA has confirmed that the application is complete and the agency is beginning its review procedure. The application is supported by the results of Phase ...

SMC 021 fails Phase III trial for Post Menopausal Osteoporosis

SMC 021, an oral salmon calctonin from Novartis, failed to meet main fracture reduction endpoints in Study 2303 a study of Post Menopausal Osteoporosis and to demonstrate a significant difference between treatment groups at three years for the primary endpoint of reducing new vertebral fractures. Similarly no statistical significant response was observed on key secondary endpoints such as new non-vertebral ...

Rheumatoid Arthritis Trial shows week 12 response to Cimzia (UCB) predicts response at 1 year.

A post-hoc analysis suggests that in patients with moderate to severe (RA), activity response rates to Cimzia (certolizumab pegol) plus methotrexate (MTX), from UCB, as early as Week 12 helped predict the effect on structural joint damage at one year. The study examined whether RAPID3 or EULAR responses at Week 12 predicted structural joint damage at one year (defined as ...

Enbrel (Amgen/Pfizer) shows clear benefits for patients with moderately active Rheumatoid Arthritis

Results from a multi-centre trial in patients with moderately active Rheumatoid Arthritis (RA)showed that the percentage who maintained low disease activity or achieved clinical remission at week 88 was significantly higher in those receiving Enbrel (etanercept), from Amgen and Pfizer) plus methotrexate (MTX) than those on MTX alone. Patients with moderately active RA represent the largest RA population, yet they ...

Juvenile Idiopathic Arthritis patients receiving Enbrel (Amgen/Pfizer) show excellent response

In patients with Juvenile Idiopathic Arthritis (JIA) who initiated treatment with the drug Enbrel (etanercept),from Amgen and Pfizer, one-third achieved an excellent response, and this response was associated with low measures of disability at study entry, younger age at the onset of JIA, and fewer disease-modifying antirheumatic drugs used before initiating etanercept, according to a study appearing in JAMA. The ...

Humira (Abbott) and other tumour necrosis factor-antagonists are not linked to increased serious infection rate

A new study shows that treatment of autoimmune diseases such as Rheumatoid Arthritis (RA) and Psoriasis with tumour necrosis factor-a antagonists (TNF-a antagonists), including Humira (adalimumab), from Abbott, is not linked to an increased risk of hospitalisation with serious infections, in comparison to using nonbiologic medications. This is important since a number of studies have reported serious infections in users ...

ACZ 885 success in Systemic Juvenile Idiopathic Arthritis

New pivotal Phase III data showing 45% of children with active systemic juvenile idiopathic arthritis (SJIA) were able to substantially reduce their use of oral corticosteroids (often described as steroids) within 28 weeks of commencing treatment with ACZ885 (canakinumab) from Novartis (p<0.0001).These data are very welcome because nearly half of ACZ885-treated patients were able to reduce their steroid use during ...

Lower dose of corticosteroids as effective as higher dose for Shoulder Pain

A study of two common corticosteroid doses administered for Shoulder Pain reveals that lower doses are as effective as higher ones for pain reduction, duration of efficacy and improved range of motion. Investigators led by Seung-Hyun Yoon, from the Department of Physical Medicine and Rehabilitation, Ajou University School of Medicine, Suwon, Republic of Korea, conducted a clinical trial in which ...

Lipitor ineffective for Atherosclerosis in pediatric Lupus

A trial to determine the efficacy and safety of Lipitor (atorvastatin), from Pfizer, in preventing subclinical Atherosclerosis progression in pediatric-onset Systemic Lupus Erythematosus (SLE) found that the therapy was ineffective in reducing Atherosclerosis progression in children and adolescents. However results from the trial showed that the treatment could benefit patients with more severe SLE who were not included in the ...

NICE recommends Mepact for Osteosarcoma

NICE,the health technology appraisal institute for England and Wales, has published final guidance recommending Mepact (mifamurtide)from Takeda in combination with post-operative multi-agent chemotherapy as an option for treating high-grade resectable non-metastatic osteosarcoma in children, adolescents and young adults. This was a reversal of an earlier decision....

Afssaps refers Protelos to EMA for re-evaluation as a treatment for Post Menopausal Osteoporosis

The French regulatory agency Afssaps has decided not to suspend Protelos (strontium ranelate),the Post Menopausal Osteoporosis drug from Servier Labs. Afssaps has referred the drug to EMA and asked for a re-evaluation. There are safety concerns due to cases of venous thrombo-embolism in patients over 80 years of age (who have additional risk factors) and cases of DRESS (dry rash ...

NICE refuses to recommend Benlysta for SLE

In a draft guidance, NICE, the health technology appraisal institute for England and Wales, has provisionally rejected Benlysta (belimumab) from GlaxoSmithKline (GSK) and Human Genome Sciences (HGS), for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy. GSK plans to contest the decision....

Ostora oral calcitonin safe and effective for Osteoporosis

The Phase III ORACAL trial evaluating Ostora tablets (calcitonin oral), from Tarsa Therapeutics, for the treatment of postmenopausal Osteoporosis, has yielded positive safety and efficacy results, according to data presented at the American Society for Bone and Mineral Research 2011 Annual Meeting. The trial compared Tarsa's oral recombinant salmon calcitonin to placebo and to commercially available, synthetic salmon calcitonin administered ...

SHOTZ study shows Forteo more effective than Zometa in bone remodelling

Data from the SHOTZ study were compared showing the mechanisms of action of Forteo (teriparatide [rDNA origin] injection) from Eli Lilly and zoledronic acid (Zometa) from Novartis that evaluated histomorphometric measurements of bone remodeling in transiliac crest bone biopsies from postmenopausal women with osteoporosis. These data were presented in an oral presentation at the 2011 Annual Meeting of the American ...

Protelos risk benefit profile in PMO questioned

The transparency committee at the French health authority, HASe has been investigating pharmacoviligence data on Protelos( strontium ranelate) from Servier to see if its risk benefit profile needs to change. The drug has been associated with hyperesenitivity reactions such as rash, eosinophilia , systemic syndromes (DRESS)(16 cases) and Stevens Johnson Syndrome. EMA was critical of the Servier pharmacovigilence system and ...

ACZ 885 positive in Phase III Juvenile Idiopathic Arthritis trial

ACZ 885 (canakinumab) from Novartis results are reported of a Phase III trial in patients with systemic juvenile idiopathic arthritis (SJIA), a rare and serious childhood auto-inflammatory disease. The results, presented at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, showed all primary and secondary endpoints of the study were met. Most ACZ885 patients (83.7%) experienced at least a ...