EU Regulators Recommend Lilly's Foundayo Pill for Weight Management and Type 2 Diabetes

On October 15, 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending EU marketing authorisation for Foundayo (orforglipron), Eli Lilly's once-daily oral GLP-1 receptor agonist. According to the EMA, the recommendation covers weight management and the treatment of type 2 diabetes in adults. A CHMP opinion is not yet an approval: the European Commission makes the final decision.

For weight management, the EMA said Foundayo is intended as an adjunct to diet and physical activity in adults with a BMI of at least 30, or a BMI of 27 to under 30 with at least one weight-related condition such as prediabetes, type 2 diabetes, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For type 2 diabetes, it can be used alone when metformin is considered inappropriate, or alongside other diabetes medicines.

The EMA describes orforglipron as a small, non-peptide molecule, which is why it can be taken by mouth once a day, at any time, with or without food. That differs from oral semaglutide, which pharmaphorum notes must be taken on an empty stomach with a 30-minute wait before eating or drinking.

According to the agency, the weight-management recommendation rests on two studies in 4,740 adults with obesity or overweight. After 72 weeks, participants on Foundayo lost around 5% to 11% of body weight depending on dose, compared with around 2% to 2.5% on placebo. In four main diabetes studies involving 3,765 adults, Foundayo lowered HbA1c by around 1.2 to 1.9 percentage points, versus 0.4 to 0.8 with placebo, 0.8 with dapagliflozin 10 mg, and 1.2 to 1.5 with oral semaglutide 7 mg and 14 mg. The most common side effects were nausea, vomiting and diarrhoea, which the EMA said were more frequent during dose increases.

CNBC reported that Foundayo is the second oral obesity drug to win the agency's backing after Novo Nordisk's Wegovy pill, which received EU approval in July. Foundayo launched in the U.S. in April and in the UK in August, and CNBC reported second-quarter sales of $98 million. Pharmaphorum notes the European Commission generally acts on CHMP recommendations within a few weeks.

Even after a Commission decision, pricing and reimbursement are set country by country, so availability and cost in any given EU member state may lag the authorisation, according to the EMA. Readers in Europe interested in an oral option should ask their clinician or pharmacist when Foundayo is expected to be prescribable and covered locally, and should rely on the summary of product characteristics, which the EMA will publish after authorisation, rather than on headline trial percentages.