Savara has announced that the FDA is giving itself extra time to review the company’s BLA for molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis, setting November 22, 2026 as the new PDUFA date. The company announced in February 2026 that the FDA had accepted the BLA for priority review with a decision date set for August 2026. A marketing application for Molbreevi is also currently under review in the UK.
According to Savara, the agency had requested additional information regarding the BLA, leading to the extension of the time needed to review the materials. The company noted that the FDA has not expressed any concerns about safety, efficacy, or manufacturing. The FDA issued a Refuse to File letter to an earlier BLA submission for Molbreevi in May 2025, and Savara re-submitted the application in October 2025.
The FDA has granted Molbreevi Breakthrough Therapy, Fast Track, and orphan drug designations. In the UK, Molbreevi has been granted Promising Innovative Medicine designation and Innovation Passport designation by the MHRA.
Read the Savara press release
