On 15 October 2026 the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended that Eli Lilly’s orforglipron be authorised in the EU under the name Foundayo. The EMA announced this the following day. The recommendation covers two uses in adults, each in addition to a healthy diet and physical activity. For weight management, orforglipron is intended from a BMI of 30 kg/m², and from a BMI of 27 kg/m² with at least one weight-related comorbidity. In type 2 diabetes that is not adequately controlled, it is to be used alone when metformin is not suitable, or together with other diabetes medicines.
Orforglipron is a small molecule and not a peptide. The tablet is taken once a day, at any time of day, with or without food.
Results
For type 2 diabetes the EMA relies on four studies with 3765 adults, with placebo, dapagliflozin or oral semaglutide as comparators. HbA1c fell with orforglipron by about 1.2 to 1.9 % depending on the dose, by 0.4 to 0.8 with placebo, by 0.8 with dapagliflozin 10 mg, and by 1.2 to 1.5 with oral semaglutide 7 or 14 mg. These ranges combine several studies and doses and do not allow a direct comparison of the active substances.
In two weight studies with 4740 adults, body weight fell after 72 weeks by about 5 to 11% depending on the dose, and by about 2 to 2.5% with placebo. The most frequent effects were nausea, vomiting and diarrhoea, especially during dose escalation.
The European Commission now decides. Price and reimbursement are then set by each member state. An authorisation application has been pending at Swissmedic since January 2026. In the United States, Foundayo has been authorised since April 2026, so far only for weight management.
Limits
Orforglipron is not yet authorised in the EU and will be prescription-only once authorised. Whether a medicine is suitable is decided in medical care. This item reports on the regulatory decision and is not a recommendation.