Savara Announces EMA Validation of MOLBREEVI Marketing Authorization Application for Autoimmune PAP Treatment

Savara Inc. announced the European Medicines Agency has validated the Marketing Authorization Application for MOLBREEVI in autoimmune pulmonary alveolar proteinosis. This confirms the submission is complete and the review has begun. The FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date. MOLBREEVI has the potential to be the first drug indicated for the treatment of autoimmune PAP in the U.S. and Europe.