EU drugs committee backs Lilly's orforglipron for obesity and type 2 diabetes

The Committee for Medicinal Products for Human Use based its weight-management opinion on two studies covering more than 4,740 adults who were obese or overweight, the European Medicines Agency said. One study enrolled adults without type 2 diabetes who had at least one weight-related health condition; the other enrolled adults with type 2 diabetes. For type 2 diabetes, the committee assessed four main studies in 3,765 adults whose blood glucose was not adequately controlled by diet, exercise or existing medicines. Foundayo was given alone and alongside other diabetes drugs, and compared with placebo, dapagliflozin and oral semaglutide.

The European Commission makes the final decision and typically follows the committee's recommendations within a few weeks, the agency said.

Why the EU opinion matters

If the Commission follows the advice, Foundayo would be the second oral GLP-1 receptor agonist available in the EU for weight management, after Novo Nordisk's Wegovy pill, which was approved in July for weight management only. In type 2 diabetes it would compete with Novo's Rybelsus, the oral semaglutide sold in Europe since 2020. Foundayo can be taken at any time of day without food or water restrictions, a difference from the Wegovy pill that Lilly has promoted as an advantage.

Lilly chief executive David Ricks said fewer than one in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment. Both companies are chasing a market expected to surpass $100 billion by 2030, Reuters reported.

The evidence behind the pill

The European Medicines Agency said patients treated with Foundayo lost up to 11% of their body weight in the studies behind the opinion. Lilly's ATTAIN-1 trial reported an average 12.4% loss at the highest dose among participants who remained on treatment, against 0.9% for placebo. The trial also recorded reductions in waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across the doses studied.

Orforglipron is a small non-peptide molecule that activates the GLP-1 receptor, formulated as a once-daily tablet.

The commercial scorecard

Reuters reported that Foundayo launched in the US in April and in the UK in August, and generated $98 million in sales in the second quarter. Novo's Wegovy pill generated 3.22 billion Danish crowns, or $484.50 million, in the same quarter. Foundayo has seen slower US uptake than Wegovy, which reached the market first.

Mounjaro and Zepbound together accounted for 65% of Lilly's total revenue in the first half of 2026, and Lilly has said the timing of further orforglipron approvals is a driver of near-term financial performance, Pharmaceutical Executive reported. Lilly has sought approval for orforglipron in more than 40 countries.

What happens next

Bernstein analyst Courtney Breen expects the EU rollout for obesity around the end of the year, The News reported. In the US, an FDA submission for the type 2 diabetes indication is pending after the agency cleared the obesity use in April 2026, Pharmaceutical Executive reported.

It remains unclear whether patients perceive Foundayo's convenience as compelling enough to drive broader adoption, Reuters reported.