U.S. FDA Accepts Supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz) under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)
Alexion Pharmaceuticals, Inc (ALXN)
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Source: Business Wire
- FDA sets target action date of October 19, 2019 - BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (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). The FDA has set a target action date of October 19, 2019 under the Prescription Drug User Fee Act (PDUFA).“This acceptance is an important step in our efforts to deliver a potential new standard of care to people living with this devastating disease,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “We look forward to working closely with the FDA to facilitate a rapid review of this application.”Atypical HUS, also known as com
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