The FDA has granted breakthrough therapy designation to Boehringer Ingelheim’s survodutide for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate or advanced fibrosis. Two phase 3 clinical trials, LIVERAGE and LIVERAGE-Cirrhosis, will evaluate the safety and efficacy of survodutide. Another drug, denifanstat, also received breakthrough designation for the same condition. The trials will assess whether survodutide can improve MASH and fibrosis over different treatment periods. The FDA grants breakthrough designation to expedite the development of drugs that show substantial improvement over current treatments for serious conditions. Boehringer Ingelheim believes survodutide could fundamentally change how MASH is treated.
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FDA grants breakthrough designation to survodutide for treatment of MASH
