EMA panel recommends approval of Lilly's oral GLP-1 Foundayo

The European Medicines Agency's human medicines committee recommended on October 16, 2026, that Foundayo (orforglipron) be authorized in the European Union for weight management and for the treatment of type 2 diabetes in adults ^[1]. The opinion from the Committee for Medicinal Products for Human Use, or CHMP, is an intermediate step; the European Commission must still decide whether to grant an EU-wide marketing authorization ^[1].

Foundayo is a prescription-only tablet taken once daily. It can be taken at any time of day, with or without food, and treatment starts at a low dose that is gradually increased according to how each patient responds to and tolerates the medicine ^[1]. The active substance, orforglipron, is a small, non-peptide molecule that activates the receptor for glucagon-like peptide-1 (GLP-1), a natural hormone involved in controlling appetite and blood glucose levels ^[1]. By activating those receptors, orforglipron reduces appetite and increases feelings of fullness, and it lowers blood glucose by helping the pancreas release more insulin when glucose levels are high, reducing levels of glucagon (a hormone that raises blood glucose) and helping the body respond better to insulin ^[1]. The EMA described the product as an alternative to injectable and other oral GLP-1 receptor agonists ^[1].

For weight management, the recommended use is alongside a healthy diet and physical activity in adults with obesity, defined as a body mass index (BMI) of at least 30, or overweight, defined as a BMI of at least 27 but below 30, who have at least one weight-related health problem ^[1]. For type 2 diabetes, it is recommended alongside diet and physical activity in adults whose blood glucose levels are not sufficiently controlled. It can be used alone when metformin is not appropriate, or together with other diabetes medicines ^[1].

The weight-management recommendation is based on two studies involving more than 4,740 adults with obesity or overweight. One study included adults without type 2 diabetes but with another weight-related health problem; the other included adults with type 2 diabetes ^[1]. After 72 weeks, participants treated with Foundayo lost around 5% to 11% of their body weight, depending on the dose they took, compared with around 2% to 2.5% among those who took placebo ^[1].

For type 2 diabetes, Foundayo was evaluated in four main studies involving 3,765 adults whose blood glucose was not adequately controlled with diet and physical activity alone or with other diabetes medicines ^[1]. Depending on the study, it was used alone or with other diabetes medicines and was compared with placebo, dapagliflozin or oral semaglutide. The main measure was change in HbA1c, a marker of blood glucose control. Across the studies, Foundayo reduced HbA1c by around 1.2 to 1.9 percentage points, depending on dose. That compared with reductions of 0.4 to 0.8 percentage points with placebo, 0.8 percentage points with dapagliflozin 10 mg, and 1.2 to 1.5 percentage points with oral semaglutide at doses of 7 mg and 14 mg, respectively ^[1].

The most common side effects reported with Foundayo were nausea, vomiting and diarrhea. They occurred more often while the dose was being increased and became less frequent over time ^[1].

Why it matters for patients

The recommendation covers two large groups: adults with obesity or overweight plus a weight-related health condition, and adults with type 2 diabetes that is not well controlled on their current treatment ^[1]. Obesity and overweight affect more than 2.5 billion people worldwide, and diabetes affects approximately 589 million adults aged 20 to 79, with type 2 accounting for about 90% of cases ^[1].

A once-daily tablet that can be taken at any time, with or without food, adds an option that does not require an injection ^[1]. The range of weight loss seen in the trials was wide, about 5% to 11% depending on dose, so results varied with the dose taken ^[1].

This opinion applies to the European Union. It does not change what is available elsewhere, and Foundayo's regulatory status in the United States has not been reported. Even inside the EU, the recommendation does not by itself make the medicine available: prices and reimbursement are decided by each member state, so cost and access could differ by country ^[1]. Those decisions have not been made yet.

What happens next

The CHMP opinion now goes to the European Commission, which adopts a decision on an EU-wide marketing authorization ^[1]. A date for that decision has not been reported. If an authorization is granted, decisions about price and reimbursement would then take place at the level of each member state ^[1].