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StocksMedium•7 April 2026•

1 min read

UK MHRA Accepts Savara's MOLBREEVI Application for Accelerated Review

Key Facts

1The UK MHRA has accepted the Marketing Authorisation Application (MAA) for MOLBREEVI for the treatment of autoimmune PAP.

2The application was accepted under Accelerated Review, qualifying for a 150-day assessment duration, with a decision expected in Q4 2026.

3The U.S. FDA is currently reviewing the Biologics License Application (BLA) for the same drug under Priority Review.

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Savara Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has formally accepted its Marketing Authorisation Application (MAA) for MOLBREEVI. The drug is designed to treat autoimmune pulmonary alveolar proteinosis (aPAP), a rare and serious respiratory condition. Notably, the application was accepted under the Accelerated Review procedure, which shortens the regulatory assessment period to 150 days. A final decision from the UK authorities is currently anticipated in the fourth quarter of 2026. This development follows progress in the United States, where the FDA is already reviewing the drug's Biologics License Application (BLA) under Priority Review. The acceptance of these filings represents a significant milestone for Savara as it advances toward potential commercialization in major global markets.