FDA extends review of Savara's MOLBREEVI application in autoimmune PAP
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
The U.S. Food & Drug Administration has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis. The Prescription Drug User Fee Act target action date was extended by three months to November 22, 2026. Savara said the FDA has extended the review period for the MOLBREEVI biologics license application in autoimmune PAP by three months.
Savara previously announced that the FDA had officially filed the biologics license application for MOLBREEVI, a treatment developed for autoimmune pulmonary alveolar proteinosis. The FDA’s acceptance of the BLA initiated a formal review process for MOLBREEVI.
During a company presentation, management said Savara had received a refusal to file in May of last year due to “in-process manufacturing data” the agency wanted before accepting the filing. Following a Type A meeting with the FDA, the company aligned with the agency on moving to an alternate drug substance manufacturer and on an analytical comparability protocol, completed a tech transfer to Fujifilm, and resubmitted the BLA in December with Fujifilm as the primary drug substance manufacturer.
Management said MOLBREEVI is intended for autoimmune pulmonary alveolar proteinosis, a rare lung disease with no approved pharmacological treatment option. The company said DLco reached statistical significance at 24 weeks in the IMPALA-2 study and remained statistically significant at 48 weeks as a key secondary endpoint, and it highlighted results in St. George’s Respiratory Questionnaire measures and exercise tolerance testing using exercise treadmill tests.
Outside the U.S., the company said it remains on track to file marketing authorization applications in Europe and the U.K. by the end of the first quarter. On commercial preparation, the company said its claims database analysis identified approximately 5,500 diagnosed prevalent aPAP patients in the U.S. and that it had reached line of sight to 1,000 patients, about 20% of the market.