FX.co ★ Zealand : Boehringer Gets FDA Breakthrough Therapy Designation For Survodutide In Non-Cirrhotic MASH

Zealand Pharma A/S (ZEAL) has reported that Boehringer Ingelheim has achieved a significant milestone with the U.S. Food and Drug Administration granting Breakthrough Therapy designation to survodutide (BI 456906). This therapy is a dual glucagon/GLP-1 receptor agonist aimed at treating adults dealing with non-cirrhotic MASH and moderate to advanced fibrosis (stages 2 and 3).

The Breakthrough Therapy designation is designed to speed up the development and review process for treatments that show promise in offering substantial improvements over existing therapies for serious or life-threatening conditions.

Furthermore, Boehringer Ingelheim has commenced two Phase III clinical trials to evaluate the efficacy of survodutide in adults suffering from metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis (scarring).