The US Food and Drug Administration (FDA) has approved a new indication for Wegovy (semaglutide) injection 2.4 mg, making it the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) to be FDA-approved to treat adults with MASH with moderate to advanced liver scarring (fibrosis) — but not with cirrhosis of the liver — in conjunction with a reduced calorie diet and increased physical activity.
This indication is approved based on the improvement of metabolic dysfunction-associated steatohepatitis or MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy in adults with MASH.
This FDA approval is based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis (stage F2 to F3) at week 72.
"This decision by the FDA reflects the continued progress in how we understand and treat patients with MASH, bringing us closer to care that meets the needs of people living with this disease," said Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University.
"If left untreated, MASH can lead to serious and potentially fatal outcomes. The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis."
MASH represents a significant health burden in the US, affecting approximately one in 20 people.
People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease, which may result in a delayed diagnosis.
Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer and the need for a liver transplant. Among people who are living with overweight or obesity worldwide, one in three also has MASH.
"For far too long, this disease has remained unrecognised, undiagnosed and often untreated, despite impacting so many people," said Dave Moore, Executive Vice President of US Operations, at Novo Nordisk.
"The FDA's conditional approval of Wegovy for the treatment of adults with noncirrhotic MASH marks a truly pivotal milestone and a significant step forward for the MASH community and those seeking new options."
"This builds on the expanding body of evidence demonstrating the clinical benefits of semaglutide across a range of chronic conditions, including diabetes, obesity, cardiovascular and chronic kidney disease."