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 an abnormal buildup of surfactant clogs the air sacs, hindering breathing and increasing infection risk. Molbreevi (molgramostim) is an inhaled granulocyte-macrophage colony-stimulating factor, a protein that signals the body's immune cells to clear this damaging material from the lungs. This targeted approach could help patients breathe more easily by restoring the natural cleanup process in their alveoli.
The purpose of the study is to evaluate the effectiveness of the sequential therapy with whole lung Lavage (WLL)/inhaling granulocyte-macrophage colony stimulating factor, compared to WLL only, for adult patients with severe autoimmune pulmonary alveolar proteinosis in China over a two-year period.
Source: ClinicalTrials.gov