Eindhoven: The Foundayo EMA opinion arrived on 15 October 2026, when the Committee for Medicinal Products for Human Use adopted a positive opinion on the once-daily tablet developed by Eli Lilly. The active substance is orforglipron, a GLP-1 receptor agonist, and the committee backed it for weight management and for type 2 diabetes in adults. The applicant is Eli Lilly Nederland B.V.

The Foundayo EMA opinion covers two uses. For weight management, the tablet is an adjunct to a healthy diet and physical activity, including weight loss and weight maintenance, in adults with a body mass index of at least 30, or between 27 and 30 with at least one weight-related condition such as prediabetes, hypertension or sleep apnoea. For diabetes, it is meant for adults whose type 2 diabetes is insufficiently controlled, either alone when metformin is unsuitable or alongside other diabetes medicines.

Under the Foundayo EMA opinion, the medicine comes as film-coated tablets in six strengths, from 0.8 mg to 17.2 mg. The agency says the benefit is a clinically relevant effect on blood sugar control in people with type 2 diabetes, together with a beneficial effect on body weight when combined with diet and activity. The most common side effects are digestive, namely nausea, vomiting and diarrhoea.

The EMA page does not cite individual trials, but trade press fills in the picture. Pharmaceutical Executive reports that the weight management application rests on two studies with more than 4,740 adults, and that four main diabetes studies covered 3,765 adults and compared Foundayo with placebo, dapagliflozin and oral semaglutide. Those figures come from the trade report rather than from the agency, so readers should check the full product information once it is published.

The next step after the Foundayo EMA opinion belongs to the European Commission, which issues the marketing authorisation. The EMA says the summary of product characteristics will appear on its website only after that decision, and it gives no date. The same trade report says the Commission usually follows a committee recommendation within a few weeks, which would put a decision around the end of the year.

The Foundayo EMA opinion matters for competition in a fast-growing field. Pharmaceutical Executive describes the product as the second oral GLP-1 medicine for weight management in the EU, after the oral semaglutide product that won approval in July, though that detail comes from the trade report alone. Injectable GLP-1 medicines already dominate obesity treatment, and a tablet could widen access for patients who avoid needles.

Questions of price and reimbursement will decide how many patients benefit. National health systems set those terms after the Commission acts, and the EMA opinion says nothing about cost. For now, the Foundayo EMA opinion marks a regulatory milestone, and the coming weeks will show how quickly the authorisation follows and which countries move first on coverage.