FDA Breakthrough status for Boehringer’s survodutide in MASH

8 October 2024

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for survodutide (BI 456906).

Under development at German family-owned pharma major Boehringer Ingelheim, survodutide is a dual glucagon/GLP-1 receptor agonist for the treatment of adults living with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis (stages 2 or 3).

The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments.3

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