Alexion reports that the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, for the treatment of people with atypical hemolytic uremic syndrome (aHUS) in order to inhibit complement-mediated thrombotic microangiopathy (TMA) … more
Japan’s Ministry of Health, Labour and Welfare has approved ULTOMIRIS® for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) … more
Alexion has announced presentation of new data demonstrating that ULTOMIRIS® provided consistent efficacy and safety through 52 weeks in the extension1 of the Phase 3 study of ULTOMIRIS and SOLIRIS® (eculizumab) in complement inhibitor-naïve, adult patients with PNH … more