LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the U.S. Food and Drug Administration does not plan to convene an advisory committee for its review of the MOLBREEVI biologics license application, as the agency continues evaluating the drug candidate for autoimmune pulmonary alveolar proteinosis.
The company said it received a Day 74 letter from the FDA indicating the review remains on track with a target action date of August 22, 2026, under the Prescription Drug User Fee Act.
Savara also said it has submitted a Marketing Authorization Application to the European Medicines Agency for MOLBREEVI and plans to submit an application to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency by the end of the first quarter of 2026.
“MOLBREEVI has the potential to be a first-in-class treatment for autoimmune PAP, a rare and debilitating lung disease with no approved therapeutics in the U.S. and Europe,” Savara Chair and Chief Executive Officer Matt Pauls said.
Autoimmune pulmonary alveolar proteinosis is a rare lung disease in which surfactant accumulates in the air sacs of the lungs, impairing gas exchange and causing symptoms such as shortness of breath, fatigue and cough.
Savara said MOLBREEVI has received several regulatory designations, including Fast Track and Breakthrough Therapy designations from the FDA, Orphan Drug designation from the FDA and the European Medicines Agency, and Innovation Passport and Promising Innovative Medicine designations from the United Kingdom regulator.
The company said MOLBREEVI is a recombinant human granulocyte-macrophage colony-stimulating factor being developed as an inhaled therapy delivered through the investigational eFlow nebulizer system.
Savara, a clinical-stage biopharmaceutical company based in Langhorne, Pennsylvania, focuses on treatments for rare respiratory diseases.
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