FDA grants breakthrough designation to survodutide for treatment of MASH
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The FDA has granted breakthrough therapy designation to Boehringer Ingelheim’s survodutide for the treatment of adult patients with noncirrhotic metabolic dysfunction-associated steatohepatitis and moderate or advanced fibrosis.
In a press release, the company also announced the initiation of two global phase 3 clinical trials, LIVERAGE and LIVERAGE-Cirrhosis, which will investigate the safety and efficacy of survodutide, a dual glucagon/glucagon-like peptide-1 receptor agonist.
Early this month, denifanstat (Sagimet Biosciences), an oral, once-daily fatty acid synthase inhibitor, also received breakthrough designation for the treatment of MASH with fibrosis.
“Given the significant burden of MASH and the limited therapeutic options, novel approaches are urgently needed,” Arun Sanyal, MD, professor of medicine at Virginia Commonwealth University School of Medicine and director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, said in the release. “The phase 3 LIVERAGE studies represent an exciting opportunity to investigate whether survodutide, with its dual glucagon and GLP-1 receptor agonist mechanism of action, can help address this significant medical need.”
According to the release, LIVERAGE will evaluate whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment, as well as whether it can lower the risk for end-stage liver disease after 7 years, in patients with MASH and stage 2 or 3 fibrosis. LIVERAGE-Cirrhosis will investigate whether survodutide can reduce the risk for end-stage liver disease outcomes after about 4.5 years of treatment in patients with MASH and compensated cirrhosis.
The trials will enroll approximately 1,800 and 1,590 adults, respectively, who will be randomly assigned to weekly injections of survodutide, to a maximum dose of 6 mg, or placebo.
“Our phase 3 trial program with survodutide is one of the largest of its kind in terms of countries and sites involved,” Shashank Deshpande, Boehringer Ingelheim’s head of human pharma, said in the release. “Notably, the program’s innovative design, which specifically targets advanced fibrosis, including patients living with cirrhosis due to MASH — the most in-need population — is set to redefine the treatment landscape.”
Deshpande continued: “The breakthrough therapy designation underscores that this potential best-in-class therapy has an opportunity to fundamentally change how MASH is treated.”
The FDA grants breakthrough designation to expedite development of drugs or devices intended to treat serious conditions and supported by clinical evidence indicating that the product may demonstrate substantial improvement over currently available drugs or devices. Breakthrough designation is intended to accelerate drug/device development, assessment and review for premarket approval, 510(k) clearance and de novo marketing authorization, while still meeting FDA standards for safety and effectiveness.
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