According to Savara, the FDA has issued an RTF letter in response to the company’s BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), citing insufficient CMC data. Savara completed its rolling BLA submission for Molbreevi in March 2025. The company says that it expects to request a Type A meeting with the FDA within 30 days.
Savara Chair and CEO Matt Pauls commented, “The requested CMC data outlined in the RTF letter are currently being generated, and we look forward to meeting with the FDA to align on next steps. Based on our understanding of the letter, we are confident we can thoroughly address the Agency’s request and expect to resubmit our BLA in the fourth quarter of 2025. We remain highly confident in our program for autoimmune PAP and believe that our clinical data demonstrate that Molbreevi improves pulmonary gas transfer and respiratory health-related quality of life in this rare disease.”
Pauls added, “As outlined in our annual report, we are working to establish a redundant supply chain. Pursuant to that strategy, we remain on track to complete the technology transfer with our second-source drug substance contract manufacturer in the fall. We have completed three upstream process performance qualification (PPQ) batches, are in the process of completing our downstream PPQ campaign and have begun our analytical comparability analysis.”
Molbreevi has received orphan drug designation from the EMA and Innovation Passport and Promising Innovative Medicine designations from the MHRA in addition to orphan drug, Breakthrough Therapy, and Fast Track designations from the FDA.
Read the Savara press release
