EMA Committee Recommends EU Authorization of Oral Orforglipron for Weight Management and Type 2 Diabetes

The European Medicines Agency (EMA) said on October 16, 2026 that its Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an EU-wide marketing authorization for Foundayo, the brand name for orforglipron, Eli Lilly's once-daily oral GLP-1 receptor agonist, for both weight management and type 2 diabetes in adults. The recommendation was one of six positive opinions on new medicines the CHMP adopted at its October 12-15, 2026 meeting, according to the EMA's published meeting highlights.

A CHMP positive opinion is not itself a marketing authorization. Per the EMA's own description, the opinion is 'an intermediary step on Foundayo's path to patient access' and will now be sent to the European Commission, which adopts the binding decision on whether to grant an EU-wide authorization. Novo Nordisk's oral semaglutide tablet followed the same path earlier in 2026, with the Commission issuing its decision roughly two months after the corresponding CHMP opinion. Decisions on pricing and reimbursement are then made separately by each EU member state.

For weight management, the EMA said Foundayo is intended for use alongside a reduced-calorie diet and increased physical activity in adults with obesity (a body mass index of at least 30 kg/m2) or with overweight (BMI of at least 27 but under 30 kg/m2) who have at least one weight-related health problem. The agency said its recommendation for this indication was based on two studies involving 4,740 adults with obesity or overweight, one of participants without type 2 diabetes who had another weight-related condition and one of participants with type 2 diabetes. After 72 weeks, the EMA said, participants treated with Foundayo lost approximately 5% to 11% of body weight depending on dose, compared with about 2% to 2.5% among those taking placebo.

For type 2 diabetes, the EMA said Foundayo is intended for adults whose blood glucose is not adequately controlled by diet and exercise alone, for use either on its own when metformin is not appropriate or alongside other diabetes medicines. The recommendation for this indication drew on four studies involving 3,765 adults, in which Foundayo was compared against placebo, dapagliflozin or oral semaglutide depending on the study. The agency reported that Foundayo reduced HbA1c, a marker of average blood glucose, by about 1.2 to 1.9 percentage points depending on dose, compared with reductions of 0.4 to 0.8 points with placebo, 0.8 points with dapagliflozin 10 mg, and 1.2 to 1.5 points with oral semaglutide at 7 mg and 14 mg doses.

The EMA described orforglipron as 'a small, non-peptide molecule that activates the receptor for glucagon-like peptide-1,' distinguishing it from injectable and oral peptide GLP-1 drugs such as semaglutide. The agency said the most common side effects reported with Foundayo were nausea, vomiting and diarrhea, which occurred more often during dose escalation and became less frequent over time. Foundayo would be available only by prescription, as a tablet taken once daily at any time, with or without food, starting at a low dose that is gradually increased.

Eli Lilly Nederland B.V. is listed as the applicant for the EU authorization. Orforglipron, under the Foundayo brand, received FDA approval in the United States on April 1, 2026 for chronic weight management in adults with obesity or overweight with weight-related conditions, but is not yet FDA-approved for type 2 diabetes. As of this CHMP opinion, orforglipron remained without a marketing authorization in the European Union and was not entered on Australia's Australian Register of Therapeutic Goods. This report describes a regulatory committee recommendation and published trial-level results; it is not medical or dosing guidance, and the EU authorization described here is pending a final European Commission decision.