FDA reports issues with filing review of OMS 721 for hematopoietic stem cell transplant-associated thrombotic microangiopathy.- Omeros

The FDA did not provide specific details of the deficiencies in its notification; however, in a meeting held on September 30, 2021, FDA expressed its intention to work with Omeros to resolve any issues as expeditiously as possible, but the company does not currently expect any such resolution to occur by the October 17, 2021 target action date under the Prescription Drug User Fee Act (PDUFA).

Omeros is evaluating potential next steps as it awaits additional information from FDA and 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.