Boehringer Ingelheim's Survodutide Wins FDA Breakthrough Status for MASH Treatment

The FDA designation expedites the development of survodutide, a promising dual receptor agonist, for treating non-cirrhotic MASH with moderate to advanced fibrosis.

• Survodutide, developed by Boehringer Ingelheim and Zealand Pharma, targets non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis stages 2 or 3.
• The FDA's Breakthrough Therapy designation aims to accelerate the review process for drugs showing substantial improvement over existing treatments.
• Boehringer has initiated two Phase III clinical trials, LIVERAGE and LIVERAGE-Cirrhosis, to assess survodutide's efficacy in adults with MASH and liver fibrosis.
• The trials will enroll nearly 3,400 participants globally, focusing on reducing the risk of end-stage liver disease and improving liver conditions over several years.
• Survodutide's innovative dual glucagon and GLP-1 receptor mechanism offers a novel approach to addressing the growing global burden of MASH.

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