Shares of the company tanked more than 40% on Friday.
FDA refrained from divulging details of the deficiencies
Omeros’ Biologics License Application (BLA) for Narsoplimab was accepted this year in January under the U.S. drug regulator’s “Priority Review” program.
Narsoplimab is a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Identified deficiencies, FDA added, “preclude discussion of labelling and post-marketing requirements/commitments at this time”.
The Food and Drug Administration refrained from divulging details of the deficiencies but said it wanted to work with Omeros to settle issues as quickly as possible. It also clarified that the review was still ongoing, and the notification should not be seen as its final verdict.
Omeros doesn’t expect a resolution by October 17th
Omeros, however, says any such resolution was unlikely to come by October 17th – its target action date under the PDUFA (Prescription Drug User Fee Act). The press release read:
Omeros is evaluating potential next steps as it awaits additional information from FDA and plans to obtain FDA approval for Narsoplimab in HSCT-TMA as quickly as possible.
Narsoplimab is the pioneer candidate drug for HSCT-TMA submitted to the U.S. drug regulator for approval.
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