Wegovy gets accelerated approval for fatty-liver disease with scarring
Semaglutide became the second drug cleared in the US for MASH with moderate to advanced fibrosis, on the strength of liver biopsy results at 72 weeks.
What's new
FDA granted accelerated approval to Wegovy for adults with MASH (formerly NASH) and moderate to advanced liver fibrosis, without cirrhosis.
Why it matters
MASH is common, mostly silent, and can lead to cirrhosis. Options have been very limited.
What's next
The second part of ESSENCE must show fewer liver-related events over about five years for the approval to become full.
Regulators granted accelerated approval to Wegovy, the 2.4 mg weekly semaglutide injection, for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis.
What MASH is
MASH is fatty liver disease with inflammation and cell damage. Over years it can lead to scarring (fibrosis), cirrhosis and liver cancer. It is closely tied to obesity and type 2 diabetes and usually causes no symptoms until late.
The evidence
ESSENCE is a two-part trial. Part 1 looked at liver biopsies after 72 weeks in about 800 people:
- Steatohepatitis resolved without worsening fibrosis in 62.9% on semaglutide versus 34.3% on placebo.
- Fibrosis improved without worsening steatohepatitis in 36.8% versus 22.4%.
Why "accelerated"
Accelerated approval is based on a measure that is reasonably likely to predict benefit, here biopsy findings, rather than on hard outcomes. The company must confirm the benefit. If part 2, which tracks cirrhosis and other liver events, fails, the indication can be withdrawn.
In context
Resmetirom, a thyroid hormone receptor drug and not a peptide, was the first MASH approval in 2024. Semaglutide brings a different mechanism, plus weight and blood sugar effects, to the same patients.
