Omeros Submits Narsoplimab MAA to the European Medicines Agency

Omeros says it submitted a Marketing Authorization Application to the European Medicines Agency for narsoplimab.

• Narsoplimab is for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy
  • It has been granted orphan drug designation by the EMA for treatment in hematopoietic stem cell transplant, enabling review of the MAA through the centralized procedure
• The review procedure begins in mid-July and will follow a standard review timeline
  • Committee for Medicinal Products for Human Use will conduct the scientific assessment and will issue an opinion at the end of the review
  • Opinion is typically adopted by the European Commission, with a final ...