Denmark’s Zealand Pharma and German partner Boehringer Ingelheim have won the US Food and Drug Administration’s Breakthrough Therapy status for the review of their experimental weight-loss drug for the treatment of a type of fatty liver disease.
The companies said in a statement that the FDA’s speedier review will be for the use of drug candidate survodutide in non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH).
Reuters reports that they will be starting two survodutide studies in the last of three stages of testing on humans to treat MASH and liver scarring.
Reuters article – Zealand, Boehringer win FDA breakthrough status to treat fatty liver (Open access)
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