a day ago
Novo Nordisk announces FDA approves additional indication of Wegovy
The company states: 'Novo Nordisk (NVO) announced that the US Food and Drug Administration has approved an additional indication for Wegovy based on a supplemental New Drug Application for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis in adults with moderate to advanced liver fibrosis, in combination with a reduced calorie diet and increased physical activity. The accelerated approval is based on part 1 of the ESSENCE trial, in which Wegovy(R) demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo. The clinical data from ESSENCE showed that at week 72, 36.8% of people treated with Wegovy(R) achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% treated with placebo. 62.9% of people treated with Wegovy(R) achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3% treated with placebo.'
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