FRANKFURT (Reuters) – Denmark’s Zealand Pharma and German partner Boehringer Ingelheim have won the U.S. Food and Drug Administration’s Breakthrough Therapy 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).
They added that they were starting two survodutide studies in the last of three stages of testing on humans to treat MASH and liver scarring.
(Reporting by Ludwig Burger, Editing by Friederike Heine)
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