Savara announced that it has initiated a rolling biologics license application submission for its Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company said that it will request priority review of the application when the submission is complete, which is expected in the first quarter of 2025. Savara reported in June 2024 that the Phase 3 IMPALA-2 trial of nebulized molgramostim in aPAP patients had met its primary endpoint.
In 2019, Savara met with the FDA regarding a possible BLA submission for the inhalation solution, then called Molgradex, and the FDA discouraged a submission at that time. Later that year, the FDA granted Breakthrough Therapy designation to Molgradex. Molbreevi has also received Fast Track and orphan drug designations from the FDA; orphan drug designation from the EMA; and Innovation Passport and Promising Innovative Medicine designations from the MHRA.
Savara Chair and CEO Matt Pauls commented, “Given the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe Molbreevi demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated. Initiation of the BLA is an important milestone in potentially addressing the unmet need in aPAP, for which there are no approved medicines in the US and Europe. We look forward to working closely with the FDA throughout the review process and expect to complete the submission of the rolling BLA by the end of 1Q 2025.”
Read the Savara press release.
