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Omeros Announces Extension of FDA Review Period for Narsoplimab in HSCT-TMA
-- PDUFA Date is October 17, 2021-- SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to
About this update from Omeros Corporation
[{"type":"text","content":"\n-- PDUFA Date is October 17, 2021--\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today reported that the U.S. Food and Drug Administration (FDA) will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021.\n\nAs part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request. FDA has classified the response as a major amendment, which requires additional time to review.\n\n“We’re pleased with our ongoing interactions with FDA on the narsoplimab BLA,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Omeros views the information provided in response to FDA’s information request as further supporting the application, and we look forward to making narsoplimab available to HSCT-TMA patients and their physicians as soon as possible.”\n\nThe first drug submitted to FDA for approval in HSCT-TMA, narsoplimab has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy. The BLA for narsoplimab in HSCT-TMA was accepted for filing in January 2021 under FDA’s Priority Review program.\n\nAbout Omeros Corporation\n\nOmeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell t...