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# FDA Grants Priority Review to Savara’s Molbreevi
- URL: https://www.fdaweb.com/fda-grants-priority-review-to-savaras-molbreevi/
- Published: 2026-02-20T12:00:00.000Z
- Updated: 2026-09-14T13:34:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160701

FDA has accepted for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency has set a user fee review action date of 8/22.

Autoimmune PAP is described as a rare and potentially serious lung disease marked by the accumulation of surfactant — a mixture of proteins and lipids that normally keeps the air sacs in the lungs open — within the alveoli. In healthy individuals, immune cells known as alveolar macrophages clear excess surfactant with the help of granulocyte-macrophage colony-stimulating factor (GM-CSF). In autoimmune PAP, however, antibodies neutralize GM-CSF, impairing macrophage function and leading to surfactant build-up, according to the company.