Omeros announces FDA acceptance of narsoplimab BLA resubmission

Omeros (OMER) announced that the FDA has accepted for review the resubmission of the biologics license application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The resubmission was classified as a Class 2 resubmission and pursuant to the Prescription Drug User Fee Act has been assigned a target action date for the FDA decision in late September. The BLA resubmission includes the primary set of analyses comparing overall survival for narsoplimab-treated patients to overall survival for an external control group of TA-TMA patients. Results of those analyses showed clinically meaningful and statistically significant improvements in survival associated with narsoplimab treatment. Also included in the resubmission are data describing survival in Omeros’ expanded access program in which adult and pediatric TA-TMA patients were treated with narsoplimab. Since resubmission of the BLA in late March, Omeros has received and is responding to information requests from FDA and expects an interactive review by FDA. Omeros is also preparing a marketing authorization application for narsoplimab in TA-TMA, which is targeted for submission to the European Medicines Agency later this quarter.