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Omeros Confirms Submission Of Response To FDA On BLA For Narsoplimab In Treatment Of HSCT-TMA

Omeros Corp. (OMER) confirmed Wednesday that earlier this month the company submitted to the U.S. Food and Drug Administration its response to the Agency's complete Response Letter or CRL for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy or HSCT-TMA.

The company noted that the response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab.

Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.

Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA. It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.

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