Lilly's GLP-1 Pill Foundayo Wins EU Committee Backing

Jeff's Daily Pick. Europe's drug committee just backed Lilly's GLP-1 pill. Foundayo (orforglipron) got a positive CHMP opinion on October 15 for weight management and type 2 diabetes. The European Commission still has to sign off.

In the European Union, the European Medicines Agency's human medicines committee (CHMP) adopted a positive opinion on October 15, 2026, recommending a marketing authorisation for Foundayo, the brand name of Eli Lilly's orforglipron. EMA announced it on October 16. The applicant is Eli Lilly Nederland B.V. Foundayo is a once daily tablet that activates the GLP-1 receptor, the same target as semaglutide and the GLP-1 half of tirzepatide, but it is a small, non peptide molecule built to be swallowed.

What the committee recommended

The recommendation covers two uses in adults, both alongside a healthy diet and physical activity:

• Weight management, including weight loss and maintenance, for a starting BMI of 30 or more, or 27 to under 30 with at least one weight related condition such as prediabetes or type 2 diabetes, high blood pressure, abnormal blood lipids, obstructive sleep apnea or cardiovascular disease.
• Type 2 diabetes that is not well controlled, on its own when metformin is not appropriate, or combined with other diabetes medicines.

EMA lists six film coated tablet strengths: 0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg. Treatment starts low and goes up step by step depending on response and tolerability. The tablet can be taken at any time of day, with or without food. That is the practical difference with oral semaglutide, which has to be taken on an empty stomach.

The data behind the opinion

For weight, EMA relied on two studies in 4,740 adults with obesity or overweight, one without diabetes and one with type 2 diabetes. After 72 weeks, people on Foundayo lost around 5% to 11% of their body weight depending on the dose, against about 2% to 2.5% on placebo. For diabetes, four main studies in 3,765 adults compared it with placebo, dapagliflozin or oral semaglutide. HbA1c fell by around 1.2 to 1.9 points, versus 0.4 to 0.8 on placebo, 0.8 on dapagliflozin 10 mg and 1.2 to 1.5 on oral semaglutide 7 and 14 mg. The most common side effects were nausea, vomiting and diarrhea, mostly during dose increases.

We have covered the trials in detail: the head to head against oral semaglutide in The Pill Duel, the heart safety trial against insulin in ACHIEVE-4, and results by life stage in orforglipron across menopause stages.

What happens next

The opinion now goes to the European Commission. Under the centralised procedure, the Commission's decision normally comes within 67 days of the opinion, which would put it around December 21, 2026 if the usual timeline holds. The full product information will be published by EMA after that decision. Foundayo launched in the United States in April 2026 and in the United Kingdom in August, according to Reuters, which also quoted a Bernstein analyst expecting an EU obesity launch around year end, with diabetes timing tied to reimbursement in each country.