Omeros Says FDA Needs More Information to Support Regulatory Approval for Narsoplimab

By Dave Sebastian

Omeros Corp. said the U.S. Food and Drug Administration, in a complete response letter for a biologics license application, expressed the need for more information for the regulatory approval of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

The biopharmaceutical company on Monday said the FDA expressed difficulty in estimating narsoplimab's treatment effect. It said the letter didn't raise chemistry, manufacturing and controls, safety or non-clinical issues precluding approval.

The company said it plans to ask for a type A meeting with the FDA as soon as possible.

Omeros said its management will host a conference call Monday at 8:30 a.m. eastern time about the development.

Write to Dave Sebastian at dave.sebastian@wsj.com

(END) Dow Jones Newswires

October 18, 2021 06:57 ET (10:57 GMT)

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