EMA panel backs Lilly’s oral GLP-1 Foundayo
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Eli Lilly’s Foundayo (orforglipron), a once-daily GLP-1 tablet for weight management and type 2 diabetes in adults. If approved, it will compete with Novo’s Wegovy tablet in Europe.
The weight management recommendation is based on two studies involving more than 4,740 adults with obesity or overweight. After 72 weeks, participants lost around 5% to 11% of their body weight depending on dose, compared with around 2% to 2.5% on placebo.
For type 2 diabetes, Foundayo was evaluated in four main studies involving 3,765 adults. It reduced HbA1c by around 1.2 to 1.9 percentage points depending on dose. Comparators included Novo’s oral semaglutide, which lowered HbA1c by 1.2 to 1.5 percentage points at the 7 mg and 14 mg doses. The most common side effects were nausea, vomiting and diarrhea, mainly during dose escalation.
Orforglipron is a small, non-peptide molecule, which allows it to be taken at any time of day, with or without food. The recommendation follows the CHMP’s May 2026 backing of a tablet formulation of Novo’s Wegovy, the first oral GLP-1 for weight management in the EU. The European Commission will now decide on an EU-wide marketing authorization.
Published: October 20, 2026
