By Bhanvi Satija and Puyaan Singh
May 22 (Reuters) – The European Medicines Agency recommended approval of Novo Nordisk’s weight-loss pill Wegovy, the regulator said on Friday, clearing the way for it 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, which analysts expect 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, Foundayo, was launched in April following its U.S. approval.
The pill, which Novo plans to launch in select markets outside the U.S. in the second half of 2026, contains semaglutide, the same active ingredient used in its blockbuster injectable drugs Wegovy for weight loss and Ozempic for diabetes.
EMA’s recommendation was based on data from a late-stage study in which patients taking the 25-milligram Wegovy pill lost an average 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.
“Needle aversion is an under-discussed but real barrier in obesity care, and a once-daily pill addresses that directly,” said Dr. Anita Phung, research physician and medical monitor at Lindus Health.
Phung also said “regulatory success does not automatically translate into clinical availability at scale,” adding “national reimbursement processes vary considerably across Europe … (injectable Wegovy) remains restricted in many (EU) member states, often channeled through specialist weight management services rather than reimbursed at primary care level.”
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 and Bhanvi Satija in London; Editing by Tasim Zahid)
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