FDA Extends Review Period for Savara's Molgramostim Application in Autoimmune PAP
Savara Inc., a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its Biologics License Application (BLA) for molgramostim, a treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The FDA's decision to extend the review by three months, setting a new target action date of November 22, 2026, follows the company's submission of additional information that the FDA deemed a major amendment to the BLA. Despite the extension, the FDA has not raised any safety, efficacy, or manufacturing concerns. Molgramostim, which has received Fast Track and Breakthrough Therapy Designations, is designed to address the rare lung disease characterized by the build-up of surfactant in the alveoli, impairing gas transfer and causing symptoms like shortness of breath and fatigue. 
