Boehringer Ingelheim Earns FDA Breakthrough Designation for Survodutide in MASH with Advanced Liver Fibrosis
The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to Boehringer Ingelheim’s survodutide (BI 456906). This dual agonist targets both glucagon and GLP-1 receptors and is designed to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) without cirrhosis, as well as those with moderate to advanced liver fibrosis (stage 2 or 3).
This designation aims to expedite the development and review of treatments for serious diseases with preliminary evidence suggesting substantial improvement over existing options.
Boehringer has also launched two Phase III trials for survodutide, known as LIVERAGE and LIVERAGE-Cirrhosis:
LIVERAGE will evaluate the drug's effectiveness in improving MASH and fibrosis over 52 weeks and reducing risks of end-stage liver outcomes over seven years in adults with MASH and moderate to advanced fibrosis.
LIVERAGE-Cirrhosis will assess survodutide’s potential to reduce end-stage liver disease risks over four and a half years in adults with MASH and compensated cirrhosis (fibrosis stage 4).
Both trials will use randomized weekly injections of survodutide or placebo, targeting a maximum dosage of 6 mg. Key endpoints for LIVERAGE include MASH resolution without fibrosis worsening and fibrosis improvement without MASH progression after one year, and long-term evaluation of liver-related events or mortality.
LIVERAGE-Cirrhosis primarily aims to assess all-cause mortality and liver-related outcomes over four and a half years.
Survodutide is part of the research focused on cardiovascular, renal, and metabolic diseases and is undergoing an extensive Phase III clinical programme. Alongside MASH trials, survodutide is also being studied in the SYNCHRONIZE programme for treating overweight or obesity.
MASH, a chronic liver disease resulting from excess fat accumulation, is a severe form of metabolic dysfunction-associated steatotic liver disease (MASLD) and is expected to rise significantly in prevalence. MASH severity is classified on a fibrosis scale from F0 (no fibrosis) to F4 (cirrhosis).
This disease is closely linked with obesity and other metabolic conditions, emphasizing the urgent need for effective therapies.
