FDA grants Wegovy accelerated approval for noncirrhotic MASH F2-F3

The U.S. Food and Drug Administration has granted accelerated approval for Wegovy, Novo Nordisk’s semaglutide 2.4 mg weekly injection, to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in those with moderate to advanced liver fibrosis (stages F2 to F3). The approval relies on early results from the ESSENCE trial, which showed meaningful improvements in liver histology after 72 weeks of treatment when Wegovy was added to diet and exercise, with a commitment from the company that a second, longer-term study will determine whether the drug reduces liver-related clinical events. Wegovy remains not indicated for patients with cirrhosis.

In Part 1 of ESSENCE, Wegovy demonstrated statistically significant liver benefits compared with placebo. At week 72, 62.9% of participants receiving Wegovy achieved resolution of steatohepatitis without worsening fibrosis, versus 34.1% in the placebo group. Additionally, 37% of Wegovy-treated participants showed improvement in liver fibrosis without worsening steatohepatitis, compared with 22.5% on placebo. A notable share, about one-third of those on Wegovy, achieved both resolution of steatohepatitis and...