Savara receives UK regulatory acceptance for rare lung disease drug

Savara Inc. (NASDAQ: SVRA) announced that the UK's Medicines and Healthcare products Regulatory Agency has accepted its marketing authorization application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis.

The application was accepted under accelerated review with a 150-day assessment period. A decision is expected in the fourth quarter of 2026.

The drug is currently under review by multiple regulatory agencies. The U.S. Food and Drug Administration is conducting a priority review of the biologics license application with a decision date of August 22, 2026. In Europe, the Committee for Medicinal Products for Human Use is reviewing the marketing authorization application with a decision expected in the first quarter of 2027.

MOLBREEVI has received several regulatory designations including Fast Track and Breakthrough Therapy status from the FDA, Orphan Drug Designation from both the FDA and European Medicines Agency, and Innovation Passport and Promising Innovative Medicine designations from the UK regulator.

Autoimmune pulmonary alveolar proteinosis is described as a rare and chronic lung disease. Savara characterizes MOLBREEVI as a potential first-in-class therapy for this condition.

The company stated that regulatory decisions across the three regions are expected within the next 12 months. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases.

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