FDA accepts Savara's MOLBREEVI application for autoimmune PAP with priority review

The FDA has accepted for review Savara’s Biologics License Application for MOLBREEVI as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency granted Priority Review with a PDUFA target action date of August 22, 2026. Savara said it plans to submit Marketing Authorization Applications to the EMA and the MHRA by the end of Q1 2026.

Savara said the application includes data demonstrating MOLBREEVI improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with this rare and debilitating lung disease. MOLBREEVI is a recombinant human granulocyte-macrophage colony-stimulating factor delivered via nebulizer. The company said MOLBREEVI has the potential to be the first and only approved therapy for autoimmune PAP in the U.S. and Europe.

In addition to Fast Track and Breakthrough Therapy designations, MOLBREEVI has been granted 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 UK’s MHRA. MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution and is not approved in any indication.

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. In autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant, causing impaired gas transfer and clinical symptoms of shortness of breath, often with cough and frequent fatigue. The disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, and MOLBREEVI is its lead program in Phase 3 development for autoimmune PAP.