Omeros submits narsoplimab marketing authorization application to the EMA

Omeros (OMER) announced the recent submission of a marketing authorization application to the European Medicines Agency for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The MAA includes response-based analyses in narsoplimab-treated TA-TMA patients as well as analyses comparing overall survival between narsoplimab-treated patients and a well-matched external control group. Collectively, the results demonstrate a 61% response rate and, compared to the matched external control, a three-fold improvement in overall survival. The submission also includes outcomes in over 130 TA-TMA patients treated with narsoplimab under Omeros’ expanded access program.