Savara says UK MHRA accepts Molbreevi filing for autoimmune PAP under accelerated review

Savara, Inc.

Savara, Inc.

SVRA

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  • Savara said U.K. MHRA accepted marketing authorization application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis.
  • MHRA granted accelerated review with 150-day assessment; decision expected in Q4 2026.
  • FDA review of Molbreevi biologics license application runs under priority review with Aug. 22, 2026 PDUFA date.
  • EU application is under CHMP review with decision expected in Q1 2027.


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