News

FDA approves Procysbi (Raptor Pharmaceutical) for Nephropathic Cystinosis

The FDA has approved Procysbi (cysteamine bitartrate) delayed release capsules, from Raptor Pharmaceutical, for the treatment of Nephropathic Cystinosis in adults and children 6 years and older. The approval was based on a New Drug Application (NDA) comprising data from six clinical trials, including a multi-center randomized, active-controlled Phase III trial of 43 patients with Nephropathic Cystinosis and extension data ...

CHMP recommends Spedra (avanafil) as a treatment for Erectile Dysfunction in adult men

Vivus, the USA-based pharmaceutical company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Spedra (Avanafil) for the treatment of erectile dysfunction in adult men.

Avanafil is a selective phosphodiesterase type 5 inhibitor which increased the percentage of sexual attempts resulting in successful intercourse by roughly 20%-30% over placebo ...

CHMP recommends Xtandi (enzalutamide) as a treatment for Prostate Cancer

Astellas Pharma Europe Ltd., the European Headquarters of Astellas Pharma Inc. and Medivation, Inc.have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Xtandi (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant Prostate Cancer whose disease has progressed on or after docetaxel therapy.

Enzalutamide is ...

Tradjenta in Phase III trial for Diabetic Nephropathy

Boehringer Ingelheim and Eli Lilly and Company have initiated a study of the efficacy and safety of Tradjenta ( linagliptin) in patients with Type 2 Diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g creatinine), while remaining on current standard therapy for Diabetic Nephropathy.

The name of the clinical trial is MARLINA (efficacy, safety & Modification ...

Phase III study shows Cialis (Eli Lilly) plus finasteride provides benefits for Benign Prostatic Hyperplasia

A new Phase III study showed Cialis (tadalafil), from Eli Lilly and Co, co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of Benign Prostatic Hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men ...

New studies support the benefits of Betmiga/Myrbetriq (Astellas) for treating Overactive Bladder

New results from clinical trials of Betmiga (mirabegron), from Astellas, support the drug's good safety and tolerability profile in treating patients with Overactive Bladder. The first of the analyses – pooled from three randomised, placebo-controlled, double-blind, 12 week trials involving a total of 4,611 patients – shows there was a four-times lower incidence of dry mouth and pruritus in patients ...

FDA recall of Omontys (Affymax/Takeda) for treatment of Anaemia in adult dialysis patients

The FDA is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection (peginesatide) by Affymax, Inc., and Takeda Pharmaceuticals Company Limited. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

Omontys was filed last year at ...

Further results from TIVO-1 study of tivozanib (Aveo Oncology/ Astellas) for Renal Cell Carcinoma treatment

AVEO Oncology and Astellas have reported final overall survival (OS) results from the comparative Phase III TIVO-1 trial with tivozanib in the treatment of advanced Renal Cell Carcinoma (RCC). The protocol-specified analysis showed that the median OS of 28.8 months (95% CI: 22.5-NA) for the oral VEGF inhibitor was less than the 29.3 months (95% CI: 29.3-NA) for Nexavar ...

PA 21( Galencia) is filed at FDA and EMA for treatment of Hyperphosphataemia in CKD patients

A New Drug Application (NDA) for PA21 from Fresenius Kabi/Galencia has been submitted to the FDA. Separately, the European Medicines Agency has accepted the Marketing Authorisation Application which was submitted December 2012 to seek approval in the European Union. Further submissions for approval are being prepared.

PA21 is a chewable, iron-based phosphate binder for the control of Hyperphosphatemia in ...

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 ...

New meta-analysis shows benefits of Xiaflex (Auxilium Pharmaceuticals) for Peyronie's disease

A meta-analysis of Phase III results assessing Xiaflex (clostridial collangase for injection), from Auxilium Pharmaceuticals, for the treatment of Peyronie's disease provides new results on previous IMPRESS studies' co-primary and secondary endpoints. Post-hoc meta-analysis from a combination of identical IMPRESS I and II studies indicates that the co-primary endpoints maintain statistical significance. In addition, the % of global responders, the ...

StJude Medical expands scope of EnligHtN RDS system in uncontrolled Hypertension with EnligHTN II trial

St. Jude Medical, Inc. has announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN Renal Denervation System in patients with uncontrolled hypertension.The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all ...

Results of REDUCE study show benefits from Avodart/Avolve (Glaxo Smith Kline) for Prostate Cancer Risk

New results from the four-year REDUCE clinical study evaluating Prostate Cancer Risk reduction in men taking Avodart/Avolve (dutasteride), from Glaxo Smith Kline, have been announced. REDUCE results showed that dutasteride decreased the risk of biopsy detectable Prostate Cancer by 22.8 percent compared to a placebo group, but concerns remained about the drug’s effectiveness. Nearly 2,800 men from the REDUCE study ...

Soliris (Alexion Pharma) rejected by UK Health Ministers for Haemolytic Uraemic Syndrome

Soliris (eculizumab)from Alexion Pharma was referred in the UK to the Advisory Group for National Specialised Services (AGNSS) instead of NICE and AGNSS recommended the $400 000 per patient, per year, drug for treatment of patients with atypical Haemolytic Uraemic Syndrome (aHUS), a rare, chronic blood disease. The decision of AGNSS was overruled by Health Ministers and the application has ...

FDA approves Botox (Allergan) as a treatment for Overactive Bladder

The FDA on 18 January 2013 expanded the approved use of Botox (onabotulinumtoxinA) from Allergan, to treat adults with Overactive Bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder’s storage capacity and reducing ...

EU approves Betmiga (Astellas) for the treatment of Overactive Bladder

Betmiga (mirabegron), from Astellas, has received approval from the European Commission for the treatment of Overactive Bladder (OAB) symptoms in adults. The European Commission granted approval of mirabegron following the recommendation by the CHMP in October 2012. They reviewed extensive clinical trial evidence from 7 Phase II / III studies in which over 5,000 patients received mirabegron, including 3 Phase ...

Votubia/Afinitor success in treatment of Renal Angiomyolipoma reported in The Lancet

Data published in The Lancet showed that patients on Afinitor (everolimus) tablets from Novartis, with non-cancerous kidney tumors known as Renal Angiomyolipomas associated with Tuberous Sclerosis Complex (TSC) experienced a significant reduction in tumor size and the absence of tumor progression. Additionally, a recent issue of The Lancet featured results from a separate everolimus trial demonstrating a reduction in ...

Phase III study of LCP-Tacro (Veloxis Pharmaceuticals) shows drug is non-inferior to current treatment in Kidney Transplant patients

New data on the 3001 Study of LCP-Tacro, from Veloxis Pharmaceuticals, in stable Kidney Transplant patients has been published. This randomized, controlled, multicenter Phase III trial demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf, dosed twice-daily. Results demonstrated that patients can be successfully converted from twice-daily Prograf to once-daily LCP-Tacro, which may increase ...

Positive data from Phase II trial of Tolenix (TheraVida) for treatment of Overactive Bladder

TheraVida has announced positive results from a Phase II clinical trial of Tolenix (tolterodine and pilocarpine) for the treatment of Overactive Bladder (OAB) and urge urinary incontinence (UUI). The aims of this randomized, double-blinded, multiple-crossover trial were to assess the safety and efficacy of Tolenix in reducing the frequency of micturition and incontinence episodes per day, as compared to both ...

IQWiG review of Inlyta(Pfizer),Nexavar (Bayer)and Afinitor (Novartis) as treatments for Renal Cell Carcinoma

IQWiG, the German drug assessment agency,recommended that Inlyta (axitinib) from Pfizer offered considerable additional benefit in the treatment of Renal Cell Carcinoma compared to Nexavar(sorafenib) from Bayer HealthCare. However it also found that Inlyta gave no additional benefit over Afinitor (everolimus) from Novartis.

Data supporting Inlyta over Nexavar came from the AXIS study. IQWiG found no difference in ...

FDA will review Procysbi (Raptor Pharma) in April 2013

Raptor Pharmaceutical Corp. announced that the FDA will require additional time to complete its review of the New Drug Application (NDA) for RP103 (Procysbi), for the potential treatment of Nephropathic Cystinosis. In a notice received from the FDA, the initial Prescription Drug User Fee Act (PDUFA) goal date has been extended from January 30, 2013 to April 30, 2013. The ...

FDA reviews Xiaflex (Auxilium Pharmaceuticals) for patients with Peyronie's disease

The FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharmaceuticals, for treatment of Peyronie's disease (PD). The FDA is expected to take action on the application by September 6, 2013. Xiaflex for the treatment of PD was granted orphan designation in the ...

Botox (Allergan) approved in Ireland for treating Overactive Bladder, the first step towards EU-wide approval

Botox (botulinum toxin type A), from Allergan, has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic Overactive Bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medications. Ireland serves as the Reference Member State in the Mutual Recognition Procedure that ...

NICE rejects Inlyta(Pfizer) for treatment of Renal Cell Carcinoma

NICE, the healthcare guidance body, has issued draft guidance not recommending Inlyta (axitinib) from Pfizer, for the treatment of advanced Kidney Cancer.The preliminary decision by the independent Appraisal Committee is that axitinib should not be recommended for the treatment of advanced Renal Cell Carcinoma after failure of prior treatment with sunitinib or a cytokine. The trial data included a ...

Rencarex (WILEX) programme in Renal Cell Carcinoma is cancelled

WILEX AG has agreed a package of restructuring measures with the company's Supervisory Board. The Executive Management Board is reacting to the results of the Phase III ARISER study with Rencarex which missed the primary endpoint. The measures are designed to tailor development activities to the remaining projects, reduce the risks inherent in the business model and lower operating ...

NICE rejects again Javlor (Pierre Fabre) as a treatment for Bladder Cancer

NICE (National Institute of Heatlth and Clinical Excellence) has rejected again the application from Pierre Fabre for Javlor (vinflunine) as a treatment for Bladder Cancer after platinum treatment has failed. NICE considered that there was insufficient evidence of clinical effectiveness compared to best supportive care. The 302 trial evidence could not be generalised to the entire UK population. There was ...

Boston Scientific acquires Vessix Vascular and its renal denervation system for Hypertension

Boston Scientific has acquired Vessix Vascular and with it the Vessix V2 Renal Denervation System for the treatment of Hypertension.Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The Vassix system now has CE Mark approval and is approved in Australia...

Phase III trial of Urocidin (Endo Pharma) for Bladder Cancer is abandoned

A Phase III clinical trial with Urocidin (mycobacterial cell wall DNA complex), from Endo Pharma, in non-muscle-invasive Bladder Cancer is being discontinued. The trial, a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive Bladder Cancer, was being run by ...

EU approves Votubia (Novartis)for Renal Angiomyolipoma

Novartis received approval from the European Commission (EC) for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. This ...

CHMP recommends Betmiga (Astellas) for patients with Overactive Bladder

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Betmiga (mirabegron), from Astellas, for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with Overactive Bladder (OAB) syndrome. If approved, mirabegron will be the first in a new class of OAB treatment, offering healthcare professionals an ...

Bardoxolone (Reata/Abbott) Phase III trial terminated for Chronic Kidney Disease

Reata Pharma, in consultation with the BEACON Steering Committee, has decided to terminate the Phase III BEACON trial of bardoxolone methyl in patients with stage 4 Chronic Kidney Disease and Type 2 Diabetes. This decision was made based upon a recommendation of the Independent Data Monitoring Committee (IDMC) to stop the trial "for safety concerns due to excess serious adverse ...

Inlyta (Pfizer) not superior to Nexavar in Renal Cell Carcinoma trial

A Phase III study AGILE 1051, of Inlyta (axitinib) from Pfizer, did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus Nexavar (sorafenib), in treatment-naïve patients with advanced Renal Cell Carcinoma (RCC).

A preliminary review of the data showed that overall the median PFS for Inlyta exceeded the median PFS for sorafenib, ...

Botox (Allergan) approved by MHRA in UK for Urinary Incontinence

The Medicines and Healthcare products Regulatory Agency (MHRA)in the UK has given Botox (botulinum toxin type A) approval for managing Urinary Incontinence caused by neurogenic detrusor overactivity(NDO) due to subcervical spinal cord injury (SCI; traumatic or non-traumatic) or multiple sclerosis (MS), but only if treatment with anticholinergics does not work. Recently published NICE Guidelines recommend the use of botulinum toxin ...

Votrient (GSK) is non inferior to Sutent ( Pfizer) in COMPRAZ study for Renal Cell Carcinoma

GSK announced that the pivotal Phase III study COMPARZ has met its primary endpoint. In the open-label, head-to-head study, Votrient (pazopanib) from GSK demonstrated non-inferiority to Sutent (sunitinib) from Pfizer in terms of progression free survival. Patients in the study were treated for advanced Renal Cell Carcinoma (mRCC) with a component of clear cell histology and had received no prior ...

Aveo files tivozanib at FDA for treatment of Renal Cell Carcinoma

AVEO Oncology and Astellas Pharma Inc. have announced that Aveo has submitted a New Drug Application (NDA) to the FDA seeking approval for tivozanib in patients with advanced Renal Cell Carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors. The NDA submission is based on ...

Astellas submits NDA for Advagraf for prophylaxis of Organ Rejection

Astellas Pharma US has submitted a New Drug Application (NDA) to the FDA seeking approval for Advagraf (tacrolimus extended release capsules) for the prophylaxis of Organ Rejection in adult kidney transplant recipients and adult male liver transplant recipients. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 ...

CHMP recommends Votubia (Novartis) for Renal Angiomyolipoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or ...

CHMP recommends approval of Cialis (Eli Lilly) for Benign Prostatic Hyperplasia

The CHMP in the EU has recommended approval of Cialis (tadalafil), from Eli Lilly and Co, for once daily use for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on ...

Results show benefits of RX Herculink Elite Stent (Abbott Vascular) in patients with Renal Artery Stenosis

Results from the HERCULES trial evaluating the safety and effectiveness of the RX Herculink Elite Stent, from Abbott Vascular, found that Renal Artery Stenosis patients with higher blood pressure levels at baseline had the most dramatic reduction in blood pressure following intervention. At the start of the trial the mean systolic blood pressure of the trial group was 162 mm ...

EC approves Inlyta (Pfizer) for Real Cell Carcinoma

The European Commission (EC) has granted marketing authorization for Inlyta (axitinib) from Pfizer for the treatment of adult patients with advanced Renal Cell Carcinoma a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine. The Inlyta data demonstrates a statistically significant improvement in progression free survival compared with sorafenib, and supports the continued role for ...

Architect Testosterone assay(Abbott) 2nd Generation receives CE Mark

Abbott has received CE Marking (Conformite Europeenne) for a testosterone assay with improved sensitivity and clinical utility. With a simple blood test, the ARCHITECT 2nd Generation Testosterone Assay can accurately measure the wide range of testosterone levels seen in a number of different patient populations and clinical settings.Testosterone assays play an important role in the diagnosis and management of many ...

Torisel (Pfizer) fails in combination trial with Avastin in Renal Cell Carcinoma

Pfizer Inc. announced that the Phase III INTORACT trial (B1771006), evaluating the combination of bevacizumab plus Torisel (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-?-2a) in the first-line treatment of patients with advanced Renal Cell Carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population. Additional efficacy endpoints ...

Updated results of TIVO-1 study of tivozanib in Renal Cell Carcinoma

Aveo Pharma and Astellas reported detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line RCC), a global, randomized, Phase III, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced Renal Cell Carcinoma (RCC). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free ...

Neupro (UCB/Schwarz) re inrroduced in US for RLS and Parkinsons Disease

Neupro(rotigotine transdermal patch) from UCB/Schwarz is now available again in the US after getting release from the FDA in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinsons Disease and moderate-to-severe primary Restless Legs Syndrome. Neupro is a once-daily patch that provides continuous delivery of the dopamine agonist rotigotine for 24 hours. The treatment was ...

FDA approves Myrbetriq (Astellas) for patients with Overactive Bladder

The FDA has approved Myrbetriq (mirabegron) extended-release tablets, from Astellas, for the treatment of Overactive Bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased ...

FDA announces guidance for licensing Zertane (Ampio Pharma) for Premature Ejaculation

Ampio Pharma has announced the outcome of its pre-IND meeting with the FDA to discuss the licensing of Zertane (oral rapidly dissolving tramadol) for Premature Ejaculation. The FDA provided guidance on the design of two Phase III pivotal clinical trials of approximately 15 weeks duration. Successful completion of these trials will allow for FDA clearance to market Zertane as a ...

Plethora/Schiele files PSD 502 at EMA for treatment of Premature Ejaculation

Plethora Solutions (a subsidiary of Sciele Pharma, a Shionogi company) has submitted a dossier to the European Medicines Agency (EMA) for the approval of PSD 502 for the treatment of Premature Ejaculation...

Positive results from IMPRESS trial of Xiaflex (Auxilium Pharma) for Peyronie's Disease

The phase III IMPRESS studies of Xiaflex (clostridial collangase for injection), from Auxilium Pharma, for treatment of Peyronie's Disease (PD) annouce positive topline results. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects and a 3.3 point improvement in the Peyronie's Disease Questionnaire bother domain. ...

CHMP recommends EU approval of Inlyta (Pfizer) for Renal Cell Carcinoma

The EMA's CHMP has recommended the marketing authorisation of Inlyta (axitinib), from Pfizer, for the treatment of adult patients with advanced Renal Cell Carcinoma, after failure of prior treatment with sunitinib or a cytokine. This drug therapy is designed to selectively inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which can influence tumour growth, ...

GSK to co pomote Testim (Auxilium Pharma) in USA

Auxilium Pharmaceuticals, and Glaxo Smith Kline have entered into an agreement to co-promote Testim (testosterone gel) testosterone replacement therapy product used in adult males. Under the terms of the agreement, Auxilium has granted GSK the exclusive right to co-promote Testim in the United States through Sept.30, 2015. GSK will promote Testim using a sizeable established field sales force which has ...

Menarini acquires rights to Priligy for Premature Ejaculation treatment

Janssen Pharmaceutica and ALZA have returned the rights to the premature ejaculation treatment Priligy (dapoxetine) to Furiex Pharmaceuticals. FuriexPharmaceuticals has licensed to Menarini rights to commercialise Priligy in Europe, most of Asia, Africa, Latin America and the Middle East. Furiex will retain development and commercialisation rights in the US, Japan and Canada. Priligy is marketed for on-demand treatment of premature ...

Phase III study of Torisel (Pfizer) for Renal Cell Carcinoma does not meet primary endpoint

The Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus), from Pfizer, in patients with advanced Renal Cell Carcinoma whose disease had progressed after sunitinib malate therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib. Although survival was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a ...

Tivozanib (Astellas) success in TIVO-1 study for Renal Cell Carcinoma

Tivozanib from Astellas/Aveo Pharma is the first treatment to demonstrate greater than one year median PFS in treatment naive patients with metastatic Renal Cell Carcinoma (pre-specified sub-analysis). Treatment with tivozanib resulted in the longest reported median PFS to date in TIVO-1 study, a pivotal study: 12.7 months compared to a median PFS of 9.1 months for sorafenib.( HR = 0.756, ...

Lucassin (Ikaria) is approved for Hepatorenal Syndrome in Australia

Australian regulators have approved Lucassin (terlipressin) from Ikaria Australia for the treatment of Hepatorenal Syndrome type 1 (HRS 1) in patients who are actively being considered for a liver transplant, making it the first approved treatment for HRS 1. The product is already approved in France, Ireland, Spain and South Korea for this indication. In the US and Canada it ...

FDA approves Stendra (Vivus Inc) for Erectile Dysfunction

The FDA has approved Stendra (avanafil) tablets, from Vivus Inc, for the treatment of Erectile Dysfunction (ED). The approval is based on a study of more than 1,200 men with ED which evaluated the efficacy and safety of Stendra. At all doses tested (50mg, 100mg and 200mg), the drug met all primary efficacy endpoints. Significant improvement in erectile function was ...

FDA approves Afinitor for treatment of Renal Angiomyolipomas

The FDA has on 26 April 2012 approved Afinitor (everolimus) tablets from Novartis for the treatment of adult patients with kidney tumors known as Renal Angiomyolipomas and Tuberous Sclerosis Complex (TSC), who do not require immediate surgery. This marks the first approval of a medical treatment in this patient population. The accelerated approval was based on the Phase III EXIST-2 ...

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....

Ampio Pharma to discuss filing with FDA of Zertane for Premature Ejaculation treatment

Ampio Pharma has submitted to the FDA a pre IND package on Zertane (oral rapidly dissolving tramadol), its on-demand Premature Ejaculation drug, for a meeting and discussion on the way forward. Zertane has successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open ...

FDA Advisory Committee recommends mirabegron(Astellas)for treatment of Overactive Bladder

Astellas Pharma Inc. has announced that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of Overactive Bladder (OAB) (Yes: 7, No: 4, Abstain: 1)....

RenalGuard (PLC Medical Systems) trial in Contrast Induced Nephropathy

Results from a new clinical trial of RenalGuard from PLC Medical Systems conducted in Italy -- the first to follow longer-term outcomes -- were presented at the annual conference of the American College of Cardiology (ACC.12), March 24 - 27, 2012, Chicago, Illinois. These results showed that RenalGuard is superior to two alternative methods at reducing rates of mortality, in-hospital ...

EOquin (Spectrum/Allergan) Phase III results in Bladder Cancer

Two double blind, randomized, placebo controlled, Phase III clinical trials for EOquin (apaziquone) as a treatment for Bladder Cancer did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms. However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor ...

Januvia approved in UK for use in renally impaired diabetic patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Januvia (sitagliptin) from Merck Inc., in the UK for use in patients suffering from moderate to severe renal impairment. As a result, another treatment will be available for individuals with sub-optimum kidney function, who represent up to one third of all those with diabetes....

Allergan seeks wider indication at FDA/EU for Botox for Overactive Bladder

Allergan has submitted a supplemental BLA with the US FDA and an application with European regulatory authorities seeking approval of Botox as treatment for of overactive bladder with symptoms of urinary incontinence, urgency and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.The product recently gained approval for another urinary condition - ...

EC 906 filed by Astellas foe EU approval for LUTS associated with BPH

Astellas Pharma Europe has filed EC 905 its fixed dose combination of Flomaxtra XL (tamsulosin) and Vesicare(solifenacin)in the Netherlands under the EU Mutual Recognition Scheme for lower urinary tract symptoms associated with Benign Prostatic Hyperplasia....

FDA approves Omontys(Affymax/Takeda)for anaemia for patients on Dialysis

The FDA has approved Omontys (peginesatide) from Affymax Inc.,/Takeda to treat Anaemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce ...

Pycnogenol (Horpagh Research) improves Menopausal transition

Pycnogenol extract from Horpagh Research Ltd, can ease Menopause and digestive problems according to a recent study. Seventy peri-menopausal randomly assigned women received either placebo or pine bark extract (100mg of Pycnogenol) daily for 8 weeks. The pine bark extract group reported a reduction in symptoms of Menopause including hot flushes, night sweats, mood swings, irregular periods,loss of libido and ...

Positive interim analysis of blisibimod (Anthera Pharma) clinical trial for SLE

The Phase IIb PEARL-SC clinical study of blisibimod, from Anthera Pharma, for Systemic Lupus Erythematosus (SLE) is recommended for continuation following an interim analysis of all safety and efficacy data. Following the review by the Company's Data Safety Monitoring Board, the study will proceed as planned without modification. PEARL-SC is examining the therapeutic benefit of weekly and monthly subcutaneous injections ...

FDA approves InTone (InControl Medical) for female Urinary Incontinence

The FDA has cleared InTone, a medical device from InControl Medical, to treat female Urinary Incontinence. InTone is the first medical device that combines mild micro-current stimulation (similar to a TENS unit), exercises and guided biofeedback to strengthen the muscles in the pelvic floor. After prescribing InTone, the physician customizes the settings for InTone and the patient is shown how ...

Solabrgron (AltheRx) success in Phase II for Overactive Bladder

Positive results are anounced by AltheRx Pharma from its Phase II study of Solabegron in Overactive Bladder (OAB) at the European Association of Urology Congress in Paris (Abstract #685).The Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study compared two dosage strengths of Solabegron (50 mg and 125 mg) to placebo in 258 women with moderate to severe OAB symptoms ...

EMA accepts MAA for Hematide (Takeda) for Anaemic adults on dialysis

The EMA has accepted Hematide (peginesatide), from Takeda, for assessment for a Marketing Authorisation Application (MAA) for the treatment of symptomatic Anaemia associated with Chronic Kidney Disease (CKD) in adult patients on dialysis. The submission was supported mainly by data from two Phase III studies (EMERALD 1 and 2) that evaluated the drug's efficacy and safety, dosed once every four ...

NX 1207 (Recordati/Nymox) starts Phase III trial for BPH

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of ...

Vitaros(Apricus BioScience) for Erectile Dysfunction rights update

Apricus BioScience has licensed, via subsidiary NextMed, the German rights to its erectile dysfunction drug,Vitaros,to Sandoz AG. The drug is approved in Canada where it is marketed by Abbott Labs and has a Complete Response Letter from the FDA where the drug is to be marketed by Warner Chilcott. The drug is filed in the EU and will be marketed ...

FDA approves Anturol (Watson Pharma) for Overactive Bladder treatment

FDA has approved Anturol (oxybutynin) from Antares Pharma/Watson Pharma as a topical gel 3% for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. The active ingredient is delivered transdermally, and not metabolized by the liver in the same way as orally administered oxybutynin. This results in a low level of side effects, such ...

FDA approves Inlyta (Pfizer) for Renal Cell Carcinoma

The FDA has approved Inlyta (axitinib)from Pfizer to treat patients with advanced kidney cancer (Renal Cell Carcinoma) who have not responded to another drug for this type of cancer. The decision was based on the AXIS 1032 study where axitinib significantly extended progression-free survival (PFS), with a median PFS of 6.7 months (95% CI, 6.3-8.6 months), compared with 4.7 months ...

New FDA drug labels for anaemia associated with Chronic Kidney Disease patients treated with ESAs

The FDA recommends caution when prescribing drugs that treat Anaemia for patients with Chronic Kidney Disease (CKD) since the drug label's recommendations fall short. The recommendations apply to erythropoiesis-stimulating agents (ESAs) such as Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa). Trials show that ESAs can increase the risk of heart-related problems such as strokes and heart attacks when ...

Pfizer will not proceed with Lyrica for Restless Legs Syndrome

Pfizer will not proceed with regulatory approval for Lyrica (pregabalin), its GABA analogue, for Restless Legs Syndrome despite reporting positive Phase III results for the drug in this patient group....

FDA advisers vote in favour of Hematide (Takeda/Affymax) approval for Anaemia

The FDA's Oncologic Drugs Advisory Committee has voted 15 to 1 that Hematide (peginesatide), from Takeda and Affymax, demonstrate a favorable benefit/risk profile for use in the treatment of dialysis patients with Anaemia due to chronic kidney disease (CKD). While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA ...

FDA Advisory Committee recommends Inlyta (Pfizer) for Renal Cell Carcinoma

The FDA Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational agent Inlyta (axitinib), the vascular endothelial growth factor (VEGF) receptor inhibitor from Pfizer, support a favorable benefit/risk profile for the treatment of patients with advanced Renal Cell Carcinoma (RCC) after failure of a first-line systemic therapy. The ODAC panel members reviewed data on ...

Toviaz(Pfizer) success in Overactive Bladder in Older Patients

Toviaz (fesoterodine fumarate) from Pfizer has met its primary endpoint in Study A0221049.This was a 12 week trial which enrolled 562 patients aged 65 or older who were randomised to either fesoterodine or placebo. Toviaz was found to be statistically significantly superior to placebo in reducing the mean number of urgency urinary incontinence episodes per day at the end of ...

Vytorin recommended for reduction of CV risk in CKD patients

A panel of outside experts at the FDA has recommended the expanded use of Vytorin (ezetimibe and simvastatin) from Merck inc. at the 10/20mg dose as a treatment for patients with chronic kidney disease (CKD not on dialysis. This would be the first drug for this indication, if approved. The recommendation is based on a review of data from the ...

Cialis Phase III study in Benign Prostatic Hyperplasia is reported in Jo.Sexual Medicine

A pivotal Phase III study of Cialis (tadalafil) tablets 5 mg from Eli Lilly and Company for once daily use met its co-primary endpoints, significantly improving measures of both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both conditions. The study is available online in The Journal of Sexual Medicine . It is ...

Cialis is FDA approved for Benign Prostatic Hyperplasia

The FDA has approved Cialis (tadalafil) tablets, the PDE 5 inhibitor marketed for erectile dysfunction ,from Eli Lilly Company, for once daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). The FDA also approved Cialis for once daily use for a separate indication for the treatment of ...

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....

FDA approves Soliris for Hemolytic Uremic Syndrome

The FDA has approved Soliris (eculizumab) from Alexion Pharma for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare, chronic blood disease that can lead to kidney failure, stroke, heart attack and death. This is the first treatment for aHUS that has been FDA-approved and the first approval for use of Soliris in children. The decision is ...

Afinitor success in phase III study with angiomyolipomas, associated with Tuberous Sclerosis Complex

A Phase III study of Afinitor (everolimus)tablets from Novartus in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors. Findings from the trial, known as EXIST-2, were presented today at the International TSC Research Conference ...

Ampio Pharma and Zertane for Premature Ejeculation

Ampio Pharma has developed an oral rapid-dissolving tablet form of the centrally acting opioid analgesic, tTramadol as a therapy for premature ejaculation. Tramadol is used in many countries for the treatment of moderate to severe pain.In a Phase III ,604 patient European trial Ampio Pharma reported positive summary results from in which the 62mg dose of Zertane (oral rapidly dissolving ...

First patients receive IMA 901 in Phase III Trial for Renal Cell Carcinoma

Immatics Biotechnologies announced that the first patients have been vaccinated in the IMPRINT study, a Phase III trial with IMA 901, the company's lead cancer vaccine for the treatment of Renal Cell Carcinoma (RCC). The trial is designed to demonstrate the overall survival benefit of IMA 901 in combination with standard first-line therapy in RCC patients. IMPRINT is a global ...

Affymax and Takeda submit NDA for Hematide

Affymax Inc. and Takeda Pharmaceutical Company Limited announced the submission of a New Drug Application (NDA) to the FDA for the investigational agent peginesatide (formerly known as Hematide) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis. The NDA includes data from two Phase III studies (EMERALD 1 and 2) that evaluated the ...

Hematide analyse of EMERALD studies

Affymax, Inc. and Takeda Pharmaceutical Company Limited announced results of additional analyses from two Phase III studies (EMERALD 1 and 2) of the investigational agent, peginesatide (formerly known as Hematide) in chronic renal failure (CRF) patients on dialysis with anemia.The EMERALD studies, showed that once-monthly peginesatide was comparable to epoetin given up to 13 times a month in maintaining hemoglobin ...