Savara Gets Refusal-to-File Letter for Molbreevi BLA

FDA has issued a Refusal-to-File (RTF) letter for a Savara BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency concluded that the submission was not sufficiently complete to permit a full review, citing the need for additional chemistry, manufacturing, and controls data, according to the company.

Savara says it will request a Type A meeting with the agency within 30 days to clarify the next steps. “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,” it says.

Molbreevi is delivered via the eFlow Nebulizer System to treat autoimmune PAP, a rare lung disease characterized by the buildup of surfactant in the alveoli, which impairs gas exchange and can lead to severe respiratory complications, the company says.