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42m ago

Novo Nordisk’s Wegovy Earns FDA Accelerated Approval for Non-Cirrhotic MASH

The clearance unlocks immediate US access pathways; confirmatory MASH outcome data are due 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 FDA’s accelerated nod covers adults with moderate-to-advanced (F2–F3) fibrosis without cirrhosis to use Wegovy alongside diet and exercise for metabolic dysfunction-associated steatohepatitis.
  • Phase 3 ESSENCE part-one showed 63% of semaglutide patients achieved steatohepatitis resolution with no fibrosis worsening versus 34% on placebo, and 37% saw fibrosis improvement without steatohepatitis worsening versus 22% with placebo.
  • Novo shares rallied up to 5% on approval news, rebounding from recent profit warnings, leadership changes and market concerns over obesity drug competition.
  • The expanded indication sets Wegovy in direct commercial rivalry with Madrigal’s Rezdiffra and looming GLP-1 entrants from Eli Lilly, prompting updated payer strategies and prescribing guidelines.
  • Approval is conditional on long-term ESSENCE part-two results expected in 2029; Novo has also filed for MASH approval in Europe and Japan and is offering lower cash prices through NovoCare and GoodRx.