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FDA Clears Wegovy for MASH, Novo Nordisk Launches $499 Cash-Pay Semaglutide Program

The approval hinges on confirmatory ESSENCE part-2 data 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 FDA granted accelerated approval for Wegovy to treat adults with moderate-to-advanced noncirrhotic MASH based on a Phase III trial.
  • ESSENCE part 1 demonstrated that 63% of patients on Wegovy achieved steatohepatitis resolution at week 72 versus 34% with placebo.
  • Novo Nordisk introduced a $499 per month self-pay option for Ozempic and Wegovy through its NovoCare service and partners like GoodRx.
  • The combined regulatory nod and pricing plan drove a roughly 4% uptick in Novo Nordisk’s share price on Monday.
  • Novo is suing more than 130 pharmacies and telehealth firms over unapproved compounded semaglutide and faces rivalry from Eli Lilly’s tirzepatide label expansions.