LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the U.S. Food and Drug Administration has accepted for review its biologics license application for MOLBREEVI as a treatment for autoimmune pulmonary alveolar proteinosis and granted the application Priority Review with a target action date of August 22, 2026.
The company said the filing relates to MOLBREEVI, a recombinant human granulocyte-macrophage colony-stimulating factor, or GM-CSF, delivered via an investigational eFlow Nebulizer System developed by PARI Pharma GmbH.
Priority Review is granted to applications for drugs that could offer significant improvements in the treatment of serious conditions and shortens the FDA’s review timeline compared with standard review.
“The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the U.S. in August of this year,” Matt Pauls, chair and chief executive officer of Savara, said in a statement. He added that the company believes the application data show improvements in pulmonary gas transfer, quality of life and clinical symptoms.
Savara said MOLBREEVI has also received Fast Track, Breakthrough Therapy and Orphan Drug designations from the FDA, as well as Orphan Drug Designation from the European Medicines Agency. The therapy has also been granted Innovation Passport and Promising Innovative Medicine designations by the United Kingdom’s Medicines and Healthcare products Regulatory Agency.
The company said it plans to submit marketing authorization applications for MOLBREEVI for autoimmune PAP to the European Medicines Agency and the U.K. regulator by the end of the first quarter of 2026.
Autoimmune PAP is a rare lung disease marked by the buildup of surfactant in the alveoli, the air sacs in the lungs, which impairs gas exchange. In the condition, autoantibodies neutralize GM-CSF, preventing immune cells known as alveolar macrophages from clearing excess surfactant, leading to shortness of breath and other respiratory symptoms.
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases and is based in Langhorne, Pennsylvania.
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