EMA backs Novo’s Wegovy pill, first oral weight-loss drug for Europe

By Bhanvi Satija and Kunal Das

May 22 (Reuters) – The European Medicines Agency recommended approval of Novo Nordisk’s 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 over a $100 billion annually in the next decade, by expanding into oral treatments.

Novo launched the oral drug 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 some 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.

The EMA said tablets may be more convenient for some patients. A 25 milligram dose of the pill helped patients lose an average 16.6% of their body weight, compared with 2.7% for those on placebo over 64 weeks in a late-stage study.

Unlike Lilly’s drug, the Wegovy pill must be taken while fasting and without other medicines, though this is not a major barrier once patients are instructed, said Tricia Tan, professor of metabolic medicine and endocrinology at Imperial College London, adding that they might struggle to remember to take it daily. Lilly’s drug is still under review by the EMA.

    Early U.S. prescription data for both oral drugs has supported the view that these can drive market expansion by bringing in new patients.

Dr. Anita Phung, research physician and medical monitor at Lindus Health said that regulatory success does not guarantee wide patient access, noting that reimbursement policies differ across Europe and injectable Wegovy is often limited to specialist services rather than primary care.

The recommendations will now be reviewed by the European Commission, which will give final marketing authorization. The agency also backed approval for a 7.2 mg dose Wegovy in a single pen, which is expected to be launched in the third quarter.

(Reporting by Kunal Das and Puyaan Singh in Bengaluru and Bhanvi Satija in London; Editing by Tasim Zahid and Shailesh Kuber)