According to Savara, the company has resubmitted its BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) with a request for priority review. Molbreevi has been granted Breakthrough Therapy and Fast Track designations by the FDA. The company had recently announced its intention to refile in the US this month.
A rolling BLA submission for Molbreevi was completed in March 2025. Citing insufficient CMC data, the FDA issued a Refuse to File letter to the application in May 2025. In the announcement of the resubmission, Savara notes that the resubmitted BLA specifies that Fujifilm Biotechnologies will manufacture the drug substance.
Read the Savara press release
