Savara announces MHRA accepted submission of Molbreevi MAA

Savara (SVRA) announced that the MHRA has accepted the submission of the Molbreevi MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Q4 2026. In the U.S., the FDA is reviewing the Molbreevi BLA under Priority Review with an August 22, 2026 Prescription Drug User Fee Act date. In Europe, the Molbreevi MAA is being reviewed by the Committee for Medicinal Products for Human Use with a decision expected in Q1 2027.