Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

Key Facts

In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval.
Omeros plans to request a Type A meeting as soon as possible with FDA to discuss the CRL and determine the most expeditious path forward for the approval of narsoplimab in the treatment of HSCT-TMA.
Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement, and Omeros is seeking FDA approval of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.
Forward-looking statements, including expectations with regard to interactions and communications with FDA and Omeros’ pursuit of regulatory approval for narsoplimab in HSCT-TMA, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release.