Posted by Michael Wonder on 02 Jan 2026
Savara resubmits the biologics license application to the US FDA for Molbreevi for the potential treatment of auto-immune pulmonary alveolar proteinosis
22 December 2025 - Savara announced today that it has resubmitted the Molbreevi BLA to the FDA, with Fujifilm as the drug substance manufacturer.
The Molbreevi biologics licence application submission is seeking approval for the treatment of auto-immune PAP, a chronic and debilitating rare lung disease characterised by the abnormal build-up of surfactant in the alveoli.
The Company has requested priority review of the application.
