Savara (NASDAQ:SVRA), a clinical-stage biopharmaceutical company dedicated to rare respiratory diseases, announced on April 7, 2026, that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its Marketing Authorisation Application (MAA) for MOLBREEVI.
The application, which seeks approval for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), has been granted Accelerated Review status.
This designation qualifies the filing for a shortened 150-day assessment period, with a final regulatory decision now anticipated in the fourth quarter of 2026.
The UK filing completes a trifecta of major regulatory submissions for Savara.
In the United States, the Food and Drug Administration (FDA) is currently reviewing the MOLBREEVI Biologics License Application (BLA) under Priority Review, with a high-stakes PDUFA action date set for August 22, 2026.
Simultaneously, the European Medicines Agency (EMA) is conducting its own review through the Committee for Medicinal Products for Human Use (CHMP), with a decision expected by the first quarter of 2027.
Autoimmune PAP is a rare and chronic lung disease characterized by the buildup of surfactant in the alveoli, which severely impairs gas exchange and can lead to respiratory failure.
MOLBREEVI, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), is designed to restore the natural clearance of surfactant by alveolar macrophages.
The therapy has received extensive regulatory support across all major jurisdictions, including Fast Track and Breakthrough Therapy Designations in the U.S. and Orphan Drug Designation in both the U.S. and Europe.
In the UK, the MHRA had previously granted MOLBREEVI its Innovation Passport and Promising Innovative Medicine (PIM) designations, recognizing the drug's potential to significantly improve patient outcomes in a life-threatening condition.