ZEALAND PHARMA AS

FDA grants Breakthrough Therapy designation to Boehringer Ingelheim’s survodutide for MASH and moderate to advanced fibrosis. Two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, will evaluate its efficacy and safety. Survodutide aims to address the significant medical need for MASH treatment.

Boehringer Ingelheim received FDA breakthrough therapy designation for survodutide, a dual GLP-1 and glucagon receptor agonist, for treating non-cirrhotic MASH and moderate or advanced fibrosis. The company initiated two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, evaluating survodutide in MASH patients with moderate or advanced fibrosis and cirrhosis, respectively. The MASH market is projected to reach $25.7bn by 2032.

Zealand Pharma reports Boehringer Ingelheim's U.S. FDA Breakthrough Therapy designation for survodutide in treating non-cirrhotic MASH and moderate or advanced fibrosis. Boehringer initiates two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, for survodutide in MASH patients with fibrosis stages 2 or 3 and cirrhosis stage 4, respectively.

Denmark’s Zealand Pharma and German partner Boehringer Ingelheim win U.S. FDA Breakthrough Therapy for review of experimental weight-loss drug survodutide, targeting non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). Two survodutide studies initiated in final human testing stages for MASH and liver scarring treatment.

The FDA granted survodutide Breakthrough Therapy designation, developed by Boehringer Ingelheim with Zealand Pharma's discoveries.

FDA grants Breakthrough Therapy designation to survodutide for treating MASH and moderate or advanced fibrosis. Boehringer Ingelheim initiates two Phase III studies, LIVERAGE and LIVERAGE-Cirrhosis, to assess survodutide's efficacy in MASH patients with fibrosis and cirrhosis.