LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the U.K.’s Medicines and Healthcare products Regulatory Agency recently accepted its marketing authorization application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, triggering an accelerated 150-day review with a decision expected in the fourth quarter of 2026.
The company said the submission follows regulatory filings already under review in the United States and Europe for the same indication, a rare lung disease.
In the United States, the Food and Drug Administration is reviewing the biologics license application under Priority Review, with a target decision date of August 22, 2026, under the Prescription Drug User Fee Act.
In Europe, the European Medicines Agency’s Committee for Medicinal Products for Human Use is reviewing the application, with a decision expected in the first quarter of 2027.
“Marketing applications for MOLBREEVI in autoimmune PAP are now being reviewed by regulatory agencies across the U.S., EU, and the U.K., all with decisions expected over the next 12 months,” said Matt Pauls, chair and chief executive officer of Savara.
MOLBREEVI has received multiple regulatory designations, including Fast Track and Breakthrough Therapy status in the United States, Orphan Drug designation from both the FDA and EMA, and Innovation Passport and Promising Innovative Medicine designations in the United Kingdom.
Autoimmune pulmonary alveolar proteinosis is a rare condition in which surfactant, a substance that helps keep air sacs open, accumulates in the lungs due to impaired clearance by immune cells. The buildup can reduce oxygen transfer and lead to symptoms such as shortness of breath, fatigue, and cough, with potential progression to severe complications including lung fibrosis or the need for transplantation.
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