May 22 (Reuters) – The European Medicines Agency recommended approval for Novo Nordisk’s weight-loss pill Wegovy, the regulator said on Friday, clearing its path to become the first oral weight-loss drug in Europe, ahead of U.S. rival Eli Lilly.
The recommendation comes as competition between Novo and Lilly intensifies, with both companies seeking to grow their share of the booming obesity drug market—expected by analysts to reach $150 billion annually in the next decade—by expanding into oral treatments.
Novo launched the pill in the United States earlier this year after winning FDA approval, giving it an early start. Lilly’s weight-loss pill, Zepbound, was launched in April following its U.S. approval.
Novo’s once-daily pill contains semaglutide, the same active ingredient used in its blockbuster injectable drugs Wegovy for weight loss and Ozempic for diabetes.
The company already sells oral semaglutide for type 2 diabetes under the brand name Rybelsus and introduced an Ozempic pill earlier this year.
“The tablets offer an oral alternative to weekly subcutaneous injections that may be more convenient for some patients,” said the EMA.
EMA’s recommendation was based on data from a late-stage study, in which patients taking the 25-milligram Wegovy pill lost an average of 16.6% of their body weight, compared with 2.7% for those on placebo over 64 weeks.
Strong early U.S. prescription data for both Novo’s and Lilly’s pills has supported the view that oral treatments can drive market expansion by bringing in new patients, rather than simply switching users from injections. Last month, the head of the European Medicines Agency, Emer Cooke, told Reuters that the EU regulatory review of the first of a new generation of weight-loss pills would be concluded this summer. The recommendations made by the EMA’s Committee for Medicinal Products for Human Use will now be reviewed by the European Commission for marketing authorization.
(Reporting by Kunal Das and Puyaan Singh in Bengaluru; Editing by Tasim Zahid)
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