#OMER "announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.
This final portion of the rolling BLA submission, comprised of the BLA’s clinical sections, follows the previously submitted chemistry, manufacturing and controls (CMC) and nonclinical sections, which are under review by FDA. The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated similarly strong response across its secondary endpoints.
Omeros has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application" (see press release HERE).
See our OMER #Narsoplimab AmpCard HERE.