Savara announced that it has completed its BLA submission for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company had announced the initiation of the rolling submission in December 2024.
In June 2024, Savara announced that the Phase 3 IMPALA-2 study had met its primary endpoint. Molbreevi, which was previously called Molgradex, received Breakthrough Therapy and Fast Track designation from the FDA. The inhalation solution has also received orphan drug designation from the EMA and Innovation Passport and Promising Innovative Medicine designations from the MHRA.
Savara Chair and CEO Matt Pauls commented, “Submission of the BLA marks an important milestone for the company and the aPAP community. We believe this unprecedented body of data demonstrates Molbreevi improves pulmonary gas exchange and the clinical symptoms associated with this rare lung disease. . . . We look forward to continuing our dialogue with the FDA and extend our gratitude to the patients and physicians who participated in our clinical trials. Our commercial preparations are on track to support a potential launch in early 2026.”
Read the Savara press release
