Posted by Michael Wonder on 08 Oct 2024
Boehringer receives US FDA breakthrough therapy designation and initiates two Phase 3 trials in MASH for survodutide
8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis and moderate or advanced fibrosis, based on survodutide’s groundbreaking results from Phase 2 study.
Boehringer Ingelheim announced today that the US FDA has granted breakthrough therapy designation for survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist for the treatment of adults living with non-cirrhotic metabolic dysfunction-associated steatohepatitis and moderate or advanced fibrosis (stages 2 or 3).
