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# FDA Extends Molgramostim BLA Review for 3 Months
- URL: https://www.fdaweb.com/fda-extends-molgramostim-bla-review-for-3-months/
- Published: 2026-04-15T12:00:00.000Z
- Updated: 2026-09-14T13:37:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160989

FDA has extended for three months until 11/22 its review of a Savara BLA for molgramostim inhalation solution to treat autoimmune pulmonary alveolar proteinosis. A company [statement](ttps://uk.finance.yahoo.com/news/savara-announces-u-food-drug-200500011.html) says the agency determined that the company’s responses to recent information requests constituted a major amendment that resulted in the extension of the PDUFA action date.

“The agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence,” Savara says. “This extension allows FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests.”

Molgramostim has received fast track, breakthrough therapy, and orphan drug designations from FDA. The company says molgramostim, its lead candidate, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis. It is delivered via an investigational eFlow nebulizer system specifically developed for the inhalation of a large molecule.