Savara Inc. announced that the European Medicines Agency (EMA) has validated the submission of the MOLBREEVI Marketing Authorization Application (MAA) in autoimmune pulmonary alveolar proteinosis (autoimmune PAP); the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the Food and Drug Administration (FDA) is reviewing the MOLBREEVI Biologics License Application (BLA) under Priority Review with an August 22, 2026 Action Date. MOLBREEVI MAA was submitted to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2026.
MOLBREEVI has been granted Fast Track and Breakthrough Therapy Designations, Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport and Promising Innovative Medicine designations by the MHRA. MOLBREEVI is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule.
MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
