LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the European Medicines Agency has validated its marketing authorization application for MOLBREEVI, initiating a formal review of the treatment for autoimmune pulmonary alveolar proteinosis, as the company continues regulatory reviews in the United States and United Kingdom.
The EMA’s Committee for Medicinal Products for Human Use will now evaluate the application, with a decision expected in the first quarter of 2027, the company said.
In the United States, the Food and Drug Administration is reviewing Savara’s biologics license application for MOLBREEVI under priority review, with a target action date of August 22, 2026.
Savara also submitted a marketing application to the U.K.’s Medicines and Healthcare products Regulatory Agency in March 2026.
“EMA’s validation of the MOLBREEVI MAA confirms the submission is complete and that the review of the application has begun,” said Matt Pauls, the company’s chair and chief executive officer.
MOLBREEVI is being developed as a treatment for autoimmune pulmonary alveolar proteinosis, a rare lung disease in which surfactant accumulates in the air sacs of the lungs, impairing gas exchange and causing symptoms including shortness of breath, fatigue and cough.
The condition occurs when immune system dysfunction prevents cells from clearing excess surfactant, potentially leading to complications such as lung fibrosis or the need for transplantation.
MOLBREEVI has received Fast Track and Breakthrough Therapy designations from the FDA, along with Orphan Drug designation from both the FDA and EMA.
The treatment has also been granted Innovation Passport and Promising Innovative Medicine designations by the U.K. regulator.
Savara said MOLBREEVI is currently in Phase 3 development and is delivered via an investigational inhalation system designed for large-molecule therapies.
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