Benzinga | May 20, 2021 08:46AM EDT

Omeros Announces Extension Of FDA Review Period For Narsoplimab In HSCT-TMA

Omeros 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.

As 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.

"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."

The 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.