According to Savara, the FDA has accepted the company’s BLA for Molbreevi mogramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis. In March 2025, Savara announced that it had completed a rolling BLA submission for Molbreevi. The FDA issued a Refuse to File letter to that application in May 2025, and Savara re-submitted the BLA in October 2025 with a request for priority review. The company says that the agency granted the priority review and set a PDUFA date of August 22, 2026.
Molbreevi has been granted Breakthrough Therapy, Fast Track, and orphan drug designations by the FDA. The molgramostim inhalation solution has also received Promising Innovative Medicine designation and Innovation Passport designation from the MHRA.
Savara Chair and CEO Matt Pauls commented, “The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the US in August of this year. We believe the considerable body of data in the application demonstrates Molbreevi improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with this rare and debilitating lung disease. We are grateful to the FDA for the constructive feedback they have provided throughout development and the review process to date and look forward to continued dialogue with the agency.”
Read the Savara press release
