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  • Boehringer Ingelheim...

Boehringer Ingelheim gets USFDA Breakthrough Therapy designation for survodutide

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-08T15:59:12+05:30  |  Updated On 8 Oct 2024 3:59 PM IST
Alembic Pharma gets USFDA EIR for Panelav facility
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Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (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 (MASH) and moderate or advanced fibrosis (stages 2 or 3).

The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments.

In addition, Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with MASH and fibrosis (scarring).

LIVERAGE will examine whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment and reduce the risk of end-stage liver disease outcomes after approximately seven years of treatment in adults living with MASH and moderate or advanced liver fibrosis (stages 2 or 3). LIVERAGE-Cirrhosis will examine whether survodutide can reduce the risk of end-stage liver disease outcomes after approximately four and a half years of treatment in adults living with MASH and compensated cirrhosis (fibrosis stage 4), a condition where the liver presents severe scarring.

“Given the significant burden of MASH and the limited therapeutic options, novel approaches are urgently needed,” said Dr. Arun Sanyal, M.D., Professor of Medicine at Virginia Commonwealth University School of Medicine and Director of VCU’s Stravitz-Sanyal Institute for Liver Disease and Metabolic Health. “The Phase III 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.”

"With the number of MASH patients expected to rise worldwide in the coming years, advancing our understanding of this condition is more crucial than ever," said Shashank Deshpande, Head of Human Pharma at Boehringer Ingelheim. "Our Phase III trial program with survodutide is one of the largest of its kind in terms of countries and sites involved. 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. The Breakthrough Therapy designation underscores that this potential best-in-class therapy has an opportunity to fundamentally change how MASH is treated."

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries.

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries. Survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardiovascular, renal and metabolic disease areas.

Read also: Boehringer Ingelheim acquires Saiba Animal Health, adding innovative technology platform to its pet therapeutics R&D portfolio

Boehringer IngelheimBoehringer Ingelheim newsUSFDAsurvodutidemetabolic dysfunction associated steatohepatitis
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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