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1h ago

Wegovy Gets FDA's First GLP‑1 MASH Approval as Novo Sets $499 Ozempic Cash Price

The authorization relies on ESSENCE phase 3 histology data with confirmation of clinical benefit expected in 2029.

Ozempic is going down in price.
A combination image shows an injection pen of Zepbound, Eli Lilly's weight loss drug, and boxes of Wegovy, made by Novo Nordisk. REUTERS/Hollie Adams/Brendan McDermid/Combination
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Overview

  • The new U.S. label covers adults with MASH and moderate‑to‑advanced fibrosis (F2–F3) without cirrhosis, to be used alongside a reduced‑calorie diet and increased physical activity.
  • In ESSENCE part 1 at week 72, 63% on semaglutide achieved steatohepatitis resolution with no fibrosis worsening versus 34% on placebo, and 37% achieved fibrosis improvement with no steatohepatitis worsening versus 22%.
  • Wegovy is the first GLP‑1 therapy cleared for MASH and will be available in the U.S. for this use immediately, entering a market that also includes Madrigal’s Rezdiffra for noncirrhotic disease.
  • Novo introduced a $499 monthly cash price for Ozempic via its NovoCare pharmacy and partners such as GoodRx, which will also list Wegovy at $499 for eligible self‑pay patients.
  • Novo Nordisk shares rose several percent on the approval and pricing news, and GoodRx jumped more than 30%, as competition from Eli Lilly and compounded semaglutide products continues.