Boehringer Ingelheim's Survodutide Receives FDA Approval

Boehringer Ingelheim has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for survodutide, a dual glucagon/GLP-1 receptor agonist for adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis. 

This designation accelerates development for a drug aimed at improving treatment outcomes for a patient population with limited treatment options. The company is launching two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, to evaluate its efficacy in this growing obesity-related condition, reports Global Newswire. 

MASH is a liver condition characterized by inflammation due to excess fat accumulation in the liver, known as steatosis. This chronic inflammation leads to progressive liver damage and can result in serious complications like fibrosis and cirrhosis. Common risk factors include being overweight (BMI of 25 or higher), metabolic syndrome, high cholesterol, high blood pressure, high blood sugar, insulin resistance, diabetes, and underactive thyroid or pituitary gland. MASH is increasingly recognized as a significant health issue associated with obesity and metabolic disorders, highlights Cleveland Clinic. 

In addition to the designation, the company announced the initiation of two Phase III clinical trials for survodutide, named LIVERAGE and LIVERAGE-Cirrhosis. LIVERAGE will evaluate the efficacy of survodutide in improving MASH and/or fibrosis after 52 weeks of treatment, and it will assess the long-term risk of end-stage liver disease outcomes over approximately seven years. The study will enroll around 1,800 adults with MASH and moderate to advanced liver fibrosis, specifically stages two or three

"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, Boehringer Ingelheim, via the company’s press release.  "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.