Horizon Therapeutics plc announced the first patient has enrolled in the ADVANCE trial evaluating the concomitant use of Krystexxa (pegloticase injection) with methotrexate for people with uncontrolled gout who were not able to achieve a complete response when previously treated with Krystexxa monotherapy.
Horizon Therapeutics announced the presentation of new Krystexxa (pegloticase injection) datasets on the primary endpoint results from the MIRROR randomized clinical trial and analyses of the pharmacokinetics of Krystexxa plus methotrexate in treating gout.
Horizon Therapeutics announced that the FDA granted priority review of the supplemental Biologics License Application (sBLA) to expand the label for Krystexxa plus methotrexate, an immunomodulator commonly prescribed by rheumatologists. The Prescription Drug User Fee Act (PDUFA) action date is July 7, 2022.
Horizon Therapeutics plc announced data from the first randomized controlled clinical trial (RCT) of Krystexxa (pegloticase injection) concomitantly used with an immunomodulator showed improved response rates as compared to Krystexxa monotherapy.
Horizon Therapeutics announced the publication of data from the first randomized controlled phase II clinical trial (RCT) of Krystexxa (pegloticase injection) in gout concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [doi.org/10.1002/art.41731].
Horizon Therapeutics plc announced that the FDA has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include Krystexxa, (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.
New results show that patients with refractory chronic Gout (RCG) who also suffer from chronic Kidney Disease (CKD) responded to...
Horizon Therapeutics announced topline results of the phase III MIRROR trial met the primary endpoint, showing a significant increase in efficacy using Krystexxa (pegloticase injection) with the immunomodulator methotrexate as compared to the response rate of Krystexxa with placebo for people with chronic gout refractory to conventional therapies – also known as uncontrolled gout.
Horizon Therapeutics announced topline results from its MIRROR open-label study in which methotrexate with Krystexxa (pegloticase injection) provided an increased...
Horizon Therapeutics announced the publication of data from the MIRROR randomized controlled clinical trial of Krystexxa (pegloticase) injection with methotrexate, a commonly used immunomodulator, in Arthritis & Rheumatology [https://doi.org/10.1002/art.42335].