On 15 October 2026 the European Medicines Agency’s human-medicines committee, the CHMP, recommended that orforglipron, sold as Foundayo, be authorised across the European Union for weight management and for type 2 diabetes. It is a recommendation, not yet an approval: the European Commission still has to adopt it. For readers in the United States nothing changes at the pharmacy, because Foundayo is already FDA-approved here. The EU wording is broader than the American label, though, and that difference is the part worth understanding.
What the committee based its opinion on
For weight management, EMA says its recommendation rests on two studies in 4,740 adults with obesity or overweight. One enrolled people without type 2 diabetes but with another weight-related condition; the other enrolled people with type 2 diabetes. After 72 weeks, participants on Foundayo lost around 5% to 11% of their body weight, depending on dose, against around 2% to 2.5% on placebo. Subtracting placebo, that is roughly 3 to 9 percentage points attributable to the drug. For someone starting at 100 kg, the agency’s ranges translate to about 5 to 11 kg lost on the drug versus 2 to 2.5 kg on placebo.
For diabetes, the committee reviewed four studies in 3,765 adults whose blood sugar was not controlled by diet and activity alone or by other diabetes medicines. Depending on the study, the comparison was placebo, dapagliflozin or oral semaglutide. HbA1c, the standard long-term blood-sugar marker, fell by around 1.2 to 1.9 percentage points on Foundayo, against 0.4 to 0.8 on placebo, 0.8 on dapagliflozin 10 mg, and 1.2 to 1.5 on oral semaglutide at 7 mg and 14 mg. The most common side effects were nausea, vomiting and diarrhoea, which EMA says were more frequent while the dose was being increased and became less frequent over time.
The recommended weight indication covers adults with a body mass index of 30 or more, or 27 to under 30 with at least one weight-related condition; EMA lists prediabetes or type 2 diabetes, high blood pressure, abnormal blood fats, obstructive sleep apnoea and cardiovascular disease as examples. The EU product page lists six tablet strengths, from 0.8 mg to 17.2 mg, the same six strengths that appear on the US label.
What it means for readers in the US
The American label, as published through the FDA’s openFDA database (NDA 220934), indicates Foundayo to reduce excess body weight and maintain that reduction in adults with obesity, or with overweight plus a weight-related condition. That label does not list type 2 diabetes as a separate indication. The EU opinion does: Foundayo on its own when metformin is considered inappropriate, or alongside other diabetes medicines. A European recommendation does not change what an American prescriber or insurer sees on the US label.
The diabetes comparisons are still informative for US readers weighing the oral options. In EMA’s summary, orforglipron’s HbA1c reductions overlap with those of oral semaglutide at its two doses, and one of the four studies compared the two directly. Our coverage of the GLP-1 class explains how these drugs differ and what their trials measured. Price will not be settled by this opinion either: EMA notes that once the Commission grants authorisation, price and reimbursement are decided separately by each member state.
What is not yet known
A CHMP opinion is an intermediate step. The full summary of product characteristics, with warnings, precautions and trial-by-trial results, will be published only after the Commission decides, so the detail behind EMA’s rounded figures is not yet public. The agency’s announcement gives ranges (“around 5% to 11%”) rather than results for each dose, and does not name the trials or say which statistical approach produced the figures, a choice that can shift reported weight loss by several points. The weight results run to 72 weeks; the announcement reports no long-term heart or mortality outcomes for the weight indication. All of the studies were sponsored by the manufacturer, Eli Lilly.
Sources: European Medicines Agency, “New oral GLP-1 medicine for weight management and type 2 diabetes,” 16 October 2026; EMA, Foundayo (orforglipron) product page, EMEA/H/C/006632, CHMP opinion adopted 15 October 2026; EMA, CHMP meeting highlights, 12 to 15 October 2026; FDA prescribing information for Foundayo (NDA 220934), label version effective 29 July 2026.
