Omeros (OMER) Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab

Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the company’s formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND). As part of FDA’s standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal. Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information. According to FDA’s interim response, the deciding official is collecting additional information, and a response to Omeros’ appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted by the deciding official.

There is no approved treatment for HSCT-TMA. The first drug candidate submitted to FDA for approval in HSCT-TMA, narsoplimab has Breakthrough Therapy and Orphan-Drug designations in this disorder as well as in IgA nephropathy.

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