Novo Nordisk Wins EU Approval for First Oral GLP-1 Weight-Loss Drug Wegovy
Bengaluru: Novo Nordisk 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.
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 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.
