Zealand, Boehringer Win FDA Breakthrough Status to Treat Fatty Liver (Medscape)

Denmark’s Zealand Pharma and German partner Boehringer Ingelheim have received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for their experimental weight-loss drug, survodutide, aimed at treating non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a type of fatty liver disease. This designation allows for a speedier review process, indicating the drug’s potential to address a significant unmet medical need.