Omeros: FDA Found Deficiencies in Review of Biologics License Application

 Omeros Corp. said the U.S. Food and Drug Administration identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangat this time.

Omeros said it was notified by the administration as part of FDA's ongoing review of the company's biologics license application for narsoplimab. The FDA stated the notification doesn't reflect a final decision on the information under review, Omeros said.

The FDA didn't provide specific details of the deficiencies in its notification. In a meeting held Sept. 30, the FDA expressed its intention to work with Omeros to resolve any issues as expeditiously as possible, Omeros said. However, the company said it doesn't currently expect any such resolution by the Oct. 17 target action date under the Prescription Drug User Fee Act.

Omeros said it is evaluating potential next steps as it awaits additional information. The company said it plans to obtain FDA approval for narsoplimab in HSCT-TMA, a frequently lethal complication of HSCT for which there is no FDA-approved treatment, as quickly as possible.

https://www.marketscreener.com/quote/stock/OMEROS-CORPORATION-5628248/news/Omeros-FDA-Found-Deficiencies-in-Review-of-Biologics-License-Application-for-Narsoplimab-36572090/