Wegovy has been approved by the US Food and Drug Administration (FDA) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advance fibrosis but without cirrhosis. What it means is that FDA has granted approval to Novo Nordisk's once-weekly 2.4 mg semaglutide subcutaneous injection for treating a liver cell damage, formerly known as NAFLD or nonalcoholic fatty liver disease. This is a condition where excess fat builds up in the liver, unrelated to heavy alcohol use. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage that could potentially lead to fibrosis and cirrhosis. It is also closely linked to metabolic disorders like obesity and type 2 diabetes, which can be treated by Wegovy. Furthermore, the condition is also closely associated with high cholesterol.ALSO READ: How To Identify A Counterfeit Ozempic? Look For These Signs How Was The Approval Given?The accelerated approval was given on the basis of part-one results from an ongoing two-part, phase 3 ESSENCE trial. This is where Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis. It also showed a resolution of steatohepatitis with no worsening of liber fibrosis as compared with placebo at week 72. The results were also published in April in The New England Journal of Medicine.How Was The Trial Conducted?The trial involved a total of 800 participants, who were assigned to either Wogovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 54. Most patients were white, which comprised of the 67.5% of the participants, 57.1% of them were women and 55.9% of them were the patients with type 2 diabetes, while 31.3% of them (around 250 patients) had stage II fibrosis and 68.8% (550 patients) had stage II fibrosis. It was noted that the patients were on stable doses of lipid-lowering , glucose-management, and weight loss medications. At week 72, the trial’s first primary endpoint revealed that 63% of the 534 participants receiving Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% of the 266 participants on placebo, a statistically significant outcome.For the second primary endpoint, 37% of those treated with Wegovy showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% in the placebo group, again demonstrating a significant difference.READ MORE: Weight Loss Drugs Like Ozempic, Mounjaro And Wegovy Under Scrutiny After Deaths And Pancreatitis Reports in UKWhat Lies Ahead For Wegovy?Novo Nordisk has moved forward with key regulatory submissions for its obesity treatments in 2025. The company filed for approval of its therapies in the European Union in February, followed by a regulatory submission in Japan in May. That same month, the U.S. Food and Drug Administration (FDA) accepted a filing for oral semaglutide 25 mg.Looking ahead, part 2 of the ESSENCE trial is expected to report results in 2029. The study is designed to evaluate whether Wegovy can reduce the risk of liver-related clinical events in patients with metabolic dysfunction–associated steatohepatitis (MASH) and F2 or F3 fibrosis, compared with placebo, over 240 weeks.While Novo Nordisk has the technology to manufacture semaglutide in pill form, the company emphasized that the U.S. launch of oral semaglutide for obesity will depend on portfolio priorities and manufacturing capacity. The higher-dose 50 mg oral version has not yet been submitted to regulators.“The oral form requires more active pharmaceutical ingredient (API),” a spokesperson told Medscape Medical News. “With a fixed amount of API, the injectable form allows us to treat more patients. We are expanding oral and injectable production capacities worldwide, but it takes time to build, validate, and scale these processes.”
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