Zealand Pharma reported that Boehringer Ingelheim announced that the FDA has granted Breakthrough Therapy designation for survodutide, a dual glucagon/GLP-1 receptor agonist for the treatment of adults living with non-cirrhotic MASH and moderate or advanced fibrosis. 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. In addition, Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with metabolic dysfunction-associated steatohepatitis and fibrosis.
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