Approval of Kayshild, sold in US as Wegovy, urged in EU for treating MASH
Committee recommends weight control med's use for severe fatty liver disease
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A committee of the European Medicines Agency (EMA) has recommended that Kayshild (semaglutide), marketed in the U.S. and Canada as Wegovy, be approved in the European Union to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease.
Specifically, the Committee for Medicinal Products for Human Use (CHMP) “adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product” in the EU.
According to the CHMP opinion, Novo Nordisk’s Kayshild would be indicated for use in combination with diet and exercise for MASH patients with moderate to advanced liver scarring, but no cirrhosis. Cirrhosis is the most advanced stage of liver scarring, or fibrosis, where widespread scarring interferes with the organ’s function.
The recommendation will be reviewed by the European Commission, which has final say over therapy approvals in the EU. The commission isn’t required to abide by CHMP’s recommendations, but almost always does.
Semaglutide, the therapy’s active ingredient, is already authorized in the EU for weight control in overweight or obese adults under the brand name Wegovy. For people ages 18 and older with type 2 diabetes, it’s authorized in Europe under the brand name Ozempic.
Wegovy was conditionally approved last year in both the U.S. and Canada to treat adults with MASH who have moderate to advanced liver fibrosis, but no cirrhosis, in combination with a low-calorie intake and increased physical activity.
Full Kayshild approval would still require clinical testing
Conditional approval allows a therapy to be brought to market based on early evidence that it will likely benefit patients. Full approval is contingent upon the developer providing additional clinical trial data confirming the therapy’s benefits.
MASH is a serious form of fatty liver disease in which excess fat builds up in the liver and causes inflammation and fibrosis, ultimately leading to damage. It often occurs alongside other metabolic conditions, including diabetes and obesity. While MASH often progresses with few or no symptoms, some patients may experience abdominal pain and fatigue.
Kayshild contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist — meaning it mimics a natural hormone called GLP-1. Among other functions, GLP-1 appears to regulate appetite by increasing a person’s feelings of fullness, while reducing food intake and cravings. It also helps control how the body processes sugar and fat.
The GLP-1 receptor protein is not found in the liver itself. Instead, Kayshild is expected to treat MASH indirectly by helping people lose excess weight, improving how the body processes sugar and fat, and reducing inflammation.
“There are currently several GLP-1 receptor agonists approved in the EU to treat diabetes and weight management,” but this would be “the first … approved in this indication,” the EMA stated in a press release sharing highlights of CHMP’s January meeting.
Positive recommendation based on data from large global study
CHMP’s recommendation is based mainly on data from the first part of a Phase 3 clinical trial called ESSENCE (NCT04822181). The global study involved 800 adults with MASH and moderate to advanced fibrosis.
The results showed that Kayshild (2.4 mg) outperformed a placebo at resolving MASH without worsening liver fibrosis. Treatment with the medication also reduced liver fibrosis without worsening liver inflammation. The most commonly reported adverse events with the therapy’s use, and at higher frequencies than those seen in the placebo group, were nausea, diarrhea, constipation, and vomiting.
The trial’s second part, expected to conclude in 2029, is evaluating Kayshild’s effects on liver-related clinical events, including cirrhosis, relative to the placebo after about 4.5 years.
Kayshild is given as an injection under the skin using a prefilled pen. If approved in the EU for MASH, it will be available in several dose strengths, at 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg.
