for Autoimmune pulmonary alveolar proteinosis (aPAP)
Originally AUG 22 2026; extended to NOV 22 2026 (Major amendment — Savara's responses to FDA information requests; FDA cited no safety, efficacy, or manufacturing concerns, announced APR 15 2026).
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease where a fatty substance builds up in the air sacs, blocking oxygen exchange and making breathing difficult. Molbreevi (molgramostim) is an inhaled version of a natural protein that activates immune cells to clear out the fatty buildup in the lungs. By restoring the lung’s ability to clean itself, Molbreevi may help patients breathe easier and reduce their risk of lung infections.
This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).
Source: ClinicalTrials.gov