Omeros Gets FDA Complete Response Letter Over Narsoplimab

Seattle-based Omeros has been hit with a Complete Response Letter (CRL) from the FDA regarding its biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

 In the CRL, the FDA said it was difficult to estimate the treatment effect of narsoplimab and that it would need to see more information to support regulatory approval, the company said.

 The first drug candidate submitted to the FDA for approval in HSCT-TMA, narsoplimab, has Breakthrough Therapy and Orphan Drug designations for HSCT-TMA and IgA nephropathy.

 Omeros said there were no chemistry, manufacturing and controls, safety or nonclinical issues raised in the CRL.

 October 20, 2021

 https://www.fdanews.com/

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