The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization in the European Union for Eli Lilly’s Foundayo (orforglipron) for weight management and the treatment of type 2 diabetes in adults, the agency announced Friday. The European Commission, which makes the final approval decision, typically follows CHMP recommendations within a few weeks.

The positive opinion marks a significant milestone in Lilly’s international expansion strategy for orforglipron, which the company has submitted for regulatory review in approximately 40 markets globally. Foundayo received FDA approval for obesity in April 2026 and launched in the United States in the second quarter of the year. An FDA submission for the type 2 diabetes indication in the US is also pending.

What CHMP Evaluated

The CHMP’s recommendation for the weight management indication is based on two studies involving more than 4,740 adults with obesity or overweight. One study enrolled adults without type 2 diabetes who had at least one weight-related health condition, while the other enrolled adults with type 2 diabetes.

For the type 2 diabetes indication, the committee evaluated four main studies involving 3,765 adults whose blood glucose was not adequately controlled with diet, physical activity, or existing diabetes medicines. Across those studies, Foundayo was used alone or in combination with other diabetes medicines and compared against placebo, dapagliflozin, and oral semaglutide.

The active substance in Foundayo, orforglipron, is a small non-peptide molecule that activates the GLP-1 receptor. As a non-peptide medicine, it is formulated for oral daily administration — and notably, unlike other oral GLP-1 therapies, can be taken at any time of day without food and water restrictions.

The Competitive Context

If the European Commission follows the CHMP’s advice — as it typically does — Foundayo would become the second oral GLP-1 receptor agonist available in the EU for weight management, following Novo Nordisk’s Wegovy pill, which received EU approval in July for weight management only. In the type 2 diabetes setting, Foundayo would compete with Novo’s Rybelsus brand of oral semaglutide, which has been marketed in the EU since 2020 and has grown into a $3 billion-plus franchise.

The CHMP recommendation opens a new competitive front between Lilly and Novo Nordisk in Europe’s oral GLP-1 market, adding to the existing competition between the two companies’ injectable incretin therapies. Mounjaro has already launched in all major European markets, and Zepbound, Lilly’s tirzepatide obesity brand, is expanding internationally.

A Growing International Footprint

Lilly’s international regulatory push for orforglipron reflects the company’s view that the obesity and type 2 diabetes markets represent a major long-term commercial opportunity well beyond the United States. Mounjaro and Zepbound together accounted for 65 percent of Lilly’s total revenue in the first half of 2026, and the company has explicitly cited the timing of additional orforglipron approvals as a key driver of near-term financial performance.

The CHMP’s positive opinion is an intermediary step — final approval authority rests with the European Commission, whose decision is expected within weeks.

Source

Eli Lilly's weight-loss pill won backing from a European drug regulator panel Quartz October 16, 2026 https://qz.com/lilly-foundayo-weight-loss-pill-eu-panel-backing-101626