SILVER SPRING
Molbreevi BLA filed for autoimmune pulmonary alveolar proteinosis
- Sponsor
- Savara Inc. $SVRA
- Drug
- Molbreevi
- Indication
- Autoimmune pulmonary alveolar proteinosis
FDA accepted Savara's BLA for Molbreevi in autoimmune pulmonary alveolar proteinosis for review.
What this means
Molbreevi is an inhaled drug designed to treat autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease where the immune system clogs air sacs with protein deposits. The FDA has begun reviewing Savara's application for approval, with a decision expected in 2024. If approved, Molbreevi could become the first targeted treatment for aPAP patients who currently rely on invasive lung washing procedures.