Novo Nordisk wins EU approval for Wegovy weight-loss pill

Eli Lilly and Company

Eli Lilly and Company

LLY

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- Novo Nordisk NOVOb.CO said on Wednesday the European Commission approved its once-daily Wegovy pill for weight management in adults with obesity or who are overweight, making it the first oral GLP-1 weight-loss treatment cleared for use across the European Union.


Here are some details:

  • The approval comes after a positive recommendation from the European Medicines Agency in May, giving the Danish drugmaker a head start in the race to dominate the emerging weight-loss pill market alongside Eli Lilly's LLY.N Foundayo, which has yet to clear the EU regulatory pathway.

  • The approval covers oral semaglutide 25 mg for adults with a body mass index of at least 30, or at least 27 with one weight-related health condition, alongside diet and exercise.

  • Novo said the approval was based on clinical trial data showing people taking the Wegovy pill lost about 17% of their body weight on average, compared with about 3% for those on placebo.

  • The company said side effects were in line with the known safety profile of injectable semaglutide. Treatment discontinuations linked to side effects were 6.9% for the pill and 5.9% for placebo, it said.

  • "This approval brings another important treatment option to people living with obesity," Novo Nordisk Chief Executive Mike Doustdar said in a statement, adding that a tablet may be simpler and more acceptable for some patients than injections.

  • The Wegovy pill is currently available in the United States, Britain and the UAE, and the company plans to launch it in more countries in the second half of 2026.