Posted by Michael Wonder on 18 Oct 2021
Omeros receives complete response letter from FDA for biologics license application for narsoplimab in the treatment of HSCT-TMA
18 October 2021 - Omeros Corporation today announced that the company received a complete response letter from the U.S. FDA regarding its biologics license application for narsoplimab in the treatment of haematopoietic stem cell transplant associated thrombotic microangiopathy.
In the complete response letter, the FDA expressed difficulty in estimating the treatment effect of narsoplimab in haematopoietic stem cell transplant associated thrombotic microangiopathy and asserted that additional information will be needed to support regulatory approval.
