MIRROR open-label study of Krystexxa shows response in gout.- Horizon Therapeutics
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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.
Swedish Orphan Biovitrum AB (publ) (Sobi) and Selecta Biosciences, Inc. announced the completion of enrolment for DISSOLVE I, the first of two clinical studies of the phase III DISSOLVE development programme of SEL 212 for chronic refractory gout.
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.