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Novo Nordisk Shares Rise on U.S. Approval of Wegovy for Liver Disease

Novo Nordisk Shares Rise on U.S. Approval of Wegovy for Liver Disease

Yahoo2 days ago
Novo Nordisk (NVO, Financials) shares climbed nearly 5% Monday after the U.S. Food and Drug Administration granted accelerated approval for its weight-loss drug Wegovy to treat metabolic dysfunction-associated steatohepatitis in adults with moderate to advanced liver fibrosis.
Warning! GuruFocus has detected 1 Warning Sign with NVO.
The approval makes Wegovy the first GLP-1 therapy cleared for MASH, a progressive liver condition affecting about 5% of U.S. adults, according to the American Liver Foundation. The drug was approved for use alongside a reduced-calorie diet and increased physical activity.
Novo Nordisk said the decision was supported by the first phase of its ESSENCE trial, which showed Wegovy patients had statistically significant improvements in liver fibrosis compared to placebo. About 63% of participants receiving Wegovy achieved resolution of steatohepatitis without worsening fibrosis, compared with 34% in the placebo group.
More than one-third of Wegovy patients also saw improvement in fibrosis without worsening steatohepatitis, versus 22% on placebo. The second phase of the trial is expected in 2029.
The company said Wegovy is immediately available in the U.S. for MASH. The only other FDA-approved treatment for the disease is Madrigal Pharmaceuticals' (MDGL, Financials) Rezdiffra, cleared in 2024.
Novo Nordisk shares were up 5.46% in London trading as of 10:43 a.m.
This article first appeared on GuruFocus.
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