AMSTERDAM — The European Medicines Agency's expert committee on Friday recommended approval of Eli Lilly's weight-loss pill Foundayo for both weight management and type 2 diabetes, clearing the way for the drug to reach European patients by the end of the year.

The Committee for Medicinal Products for Human Use adopted its positive opinion on Oct. 15 and the agency published it a day later. The European Commission, which makes the final decision on EU-wide marketing authorisation, generally follows the committee's advice within a few weeks.

The recommendation matters because it would put a second daily tablet on the European market in a field that has so far been dominated by weekly injections. Foundayo would follow Novo Nordisk's Wegovy pill, which won EU approval in July for weight management only, and it would be the first oral GLP-1 drug in Europe cleared for both obesity and diabetes at once.

Foundayo contains orforglipron, a small-molecule GLP-1 receptor agonist that reduces appetite and food intake. The EMA said the tablet is taken once a day and provides "an alternative to injectable and other oral GLP-1 receptor agonists."

For weight management, the committee's opinion rests on two studies involving more than 4,740 adults with obesity or overweight, according to the EMA. After 72 weeks, participants treated with Foundayo lost around 5% to 11% of their body weight depending on the dose, compared with around 2% to 2.5% among those who took a placebo.

The type 2 diabetes recommendation is based on four main studies in 3,765 adults whose blood sugar was not adequately controlled by diet, exercise or existing medicines, Pharmaceutical Executive reported. Foundayo was tested alone or alongside other diabetes drugs and compared against placebo, dapagliflozin and oral semaglutide.

The EMA said the most common side effects are gastrointestinal, including nausea, vomiting and diarrhoea.

The recommended indication covers adults with a body mass index of 30 or more, or 27 and above with at least one weight-related health condition, as an adjunct to diet and exercise. In diabetes, it can be used alone when metformin is considered inappropriate or in combination with other glucose-lowering medicines, according to the agency's product summary.

Lilly has pitched convenience as the drug's main advantage. Novo's oral products, Rybelsus for diabetes and the Wegovy pill for weight loss, must be taken on an empty stomach after an overnight fast, with at least 30 minutes before food, drink or other medicines, pharmaphorum reported. Foundayo can be taken at any time of day with or without food or water.

Whether patients will find that difference compelling enough to switch is an open question, Reuters reported. Foundayo's uptake in the United States has been slower than that of the Wegovy pill, which reached the market first.

The U.S. Food and Drug Administration approved Foundayo for obesity in April, and the drug launched in Britain in August. It generated $98 million in sales in the second quarter, according to Reuters, against 3.22 billion Danish crowns, or about $484.5 million, for Novo's Wegovy pill over the same period. Lilly has sought approval in more than 40 countries, and an FDA submission for the type 2 diabetes indication is pending.

Bernstein analyst Courtney Breen told Reuters she expects an EU obesity launch around the end of the year. In diabetes, she said, "launch timing depends on member-state reimbursement."

Ken Custer, president of Lilly Cardiometabolic Health, said the company would work with governments, payers and healthcare systems so that people who could benefit from Foundayo have access to it, Reuters reported.

In diabetes, Foundayo would compete directly with Rybelsus, an oral form of semaglutide that has been sold in the EU since 2020 and is a franchise worth more than $3 billion a year, according to pharmaphorum.

The stakes for both companies are large. Lilly and Novo are competing for a share of an obesity drug market that analysts expect to exceed $100 billion by 2030, Reuters reported, and early U.S. prescription data suggest pills could widen that market by reaching patients who are reluctant to inject themselves. Lilly's injectable drugs Mounjaro and Zepbound together accounted for 65% of the company's revenue in the first half of 2026, Pharmaceutical Executive reported.

Foundayo was one of six new medicines the committee recommended at its Oct. 12-15 meeting, alongside Revolution Medicines' pancreatic cancer drug Rasonque and Ascendis Pharma's achondroplasia treatment Yuviwel, according to the EMA's meeting summary. The committee also backed five extensions of existing approvals, including a pandemic influenza H5N1 vaccine from AstraZeneca.

Once the European Commission grants authorisation, the tablet will be available in six strengths ranging from 0.8 mg to 17.2 mg, the EMA said. Pricing and reimbursement will then be negotiated country by country, meaning the date European patients can actually fill a prescription will differ from one member state to the next.