Foundayo (orforglipron), Eli Lilly's once-daily GLP-1 receptor agonist tablet, has a positive opinion from the European Medicines Agency's human medicines committee for weight management and for type 2 diabetes in adults. The Committee for Medicinal Products for Human Use (CHMP) adopted it on 15 October 2026. An opinion is not a licence. Until the European Commission decision, Foundayo is not authorised anywhere in the EU, and on 21 October 2026 the EMA's own medicine page still listed an opinion, not an authorisation.
For weight, the evidence is phase 3 and placebo-controlled. For glucose, it is partly head-to-head. In ATTAIN-1, the highest orforglipron dose cut body weight by 11.2% against 2.1% on placebo over 72 weeks, a 9.1 point difference. That trial was published in the New England Journal of Medicine and funded by Eli Lilly, and the figure is its pre-registered primary end point.
Britain and the United States already license the molecule, on different labels, and each territory's decision stands on its own. Readers who want the class background can find the outcome trial record in our explainer on GLP-1 receptor agonists and cardiovascular risk.
What the CHMP recommended for Foundayo
The CHMP recommended Foundayo as an adjunct to healthy diet and physical activity for weight loss and weight maintenance in adults with a BMI of 30 or more, or 27 to under 30 with at least one weight-related comorbidity, and for adults with insufficiently controlled type 2 diabetes, alone when metformin is inappropriate or in combination.
That wording is taken from the CHMP summary of opinion EMA/CHMP/229918/2026, dated 15 October 2026, with Eli Lilly Nederland B.V. as applicant. For the overweight band it lists prediabetes or type 2 diabetes, hypertension, dyslipidaemia, obstructive sleep apnoea and cardiovascular disease as qualifying comorbidities.
Benefit, in the committee's words, is a clinically relevant effect on glycaemic control and a beneficial effect on body weight alongside diet and activity. Harms are named as gastrointestinal. Nausea, vomiting and diarrhoea are the most common.
No efficacy figures appear in the summary. It points to sections 4.4, 4.5 and 5.1 of a product information that does not exist yet, because the Foundayo product information and the European public assessment report, which carries the reviewers' reservations, are published only after the Commission grants a licence.
The 11.2% figure and the 12.4% figure
Two weight-loss numbers circulate for the top dose in ATTAIN-1. They answer different questions.
Much of the coverage of the US approval used 12.4% against 0.9% on placebo. Wharton and colleagues, in the peer-reviewed paper published online on 16 September 2025, report 11.2% against 2.1%, and Lilly's US medical information page gives both and labels 11.2% as primary.
Neither is an error. An efficacy estimand, which produced 12.4%, estimates the effect had participants stayed on treatment. A treatment-regimen estimand in the intention-to-treat population, which produced 11.2%, counts everyone randomised whether or not they kept taking the tablet.
Only one of them was pre-registered as primary. The trial's ClinicalTrials.gov record NCT05869903 registers percent change in body weight from baseline to week 72 as its primary outcome, and the paper names the treatment-regimen estimand as the primary analysis. We found no switch between protocol and publication. Measured that way, the absolute difference from placebo was 9.1 percentage points at the highest dose, 6.3 at the middle dose and 5.4 at the lowest.
ATTAIN-1 randomised 3,127 adults with obesity and without diabetes, in a 3:3:3:4 ratio across 3 doses and placebo. At the highest dose, 54.6% lost at least 10% of body weight against 12.9% on placebo, an absolute difference of 41.7 percentage points. For a loss of at least 15%, the split was 36.0% against 5.9%.
Tolerability cost something. Adverse events led to stopping treatment in 5.3% to 10.3% of participants on orforglipron and 2.7% on placebo. Placebo was the only comparator, so ATTAIN-1 says nothing about orforglipron against an injectable. Its registry entry shows the study as active, not recruiting, with completion estimated for October 2027.
Regulators quote a wider range. Folding ATTAIN-1 together with a second study in adults with type 2 diabetes, 4,740 adults in all, the EMA reports weight loss of about 5% to 11% at 72 weeks depending on dose, against about 2% to 2.5% on placebo. Because the recommended indication covers both populations, that is the honest range to quote for Foundayo as a product.
How orforglipron compares on glucose
Diabetes is where the comparator changes. According to the EMA's release of 16 October 2026, 4 main studies in 3,765 adults whose blood glucose was not adequately controlled tested orforglipron against placebo, dapagliflozin and oral semaglutide. Orforglipron lowered HbA1c by about 1.2 to 1.9 percentage points depending on dose. Placebo lowered it by 0.4 to 0.8 points, dapagliflozin by 0.8 points and oral semaglutide by 1.2 to 1.5 points.
Read as ranges, those figures overlap at the bottom with oral semaglutide, already licensed in the EU for type 2 diabetes. They do not establish superiority, and per-trial confidence intervals are not in the release. For UK readers the dapagliflozin arm matters because sodium-glucose co-transporter 2 inhibitors now sit earlier in the NICE sequence, a change covered in our report on SGLT2 inhibitors as first-line type 2 diabetes therapy.
ACHIEVE-1 gives the cleanest single read. Published in the same journal in September 2025 and also funded by Eli Lilly, it randomised 559 adults with early type 2 diabetes managed by diet and exercise, mean baseline HbA1c 8.0%, for 40 weeks.
On the primary end point, HbA1c fell by 1.24 to 1.48 percentage points across 3 doses against 0.41 on placebo, a placebo-adjusted difference of 0.83 to 1.07 points. Body weight, a key secondary end point, fell by 4.5% to 7.6% against 1.7%. No severe hypoglycaemia was reported. Discontinuation for adverse events ran at 4.4% to 7.8% on orforglipron against 1.4% on placebo.
Context: HbA1c is a surrogate end point. Its reduction is accepted for licensing in type 2 diabetes, but these trials were not designed or powered to show effects on heart attack, stroke or death.
Where Foundayo stands in the UK, EU and US
Foundayo is licensed in Great Britain by the MHRA since 10 August 2026 for weight management and type 2 diabetes, but it is not available on the NHS. In the US the FDA approved it on 1 April 2026 for weight reduction and maintenance. In the EU it holds only a CHMP opinion, pending a Commission decision.
Britain moved first in Europe. The MHRA's announcement of 10 August 2026 names Eli Lilly as licence holder and states that the medicine is not currently available on the NHS, with NHS use to follow a NICE evaluation. It also restates that all GLP-1 medicines are prescription-only and that promoting prescription-only medicines to the public is illegal.
America's label is narrower. On the FDA's novel drug approvals list for 2026, Foundayo appears on 1 April 2026 with a single use: reducing excess body weight and maintaining the reduction in adults with obesity, or overweight with at least one weight-related condition. No type 2 diabetes indication is listed. Approval in one territory is not approval in another, and the labels differ in substance.
In the EU, Novo Nordisk said on 15 July 2026 that the Commission had approved its Wegovy pill, oral semaglutide, for weight management. If the Commission follows the CHMP, Foundayo would become the second oral GLP-1 licensed in the EU for weight management.
The decisions still to come, in order
Brussels comes first. A footnote to the CHMP summary states that a Commission decision is normally issued 67 days from adoption of the opinion, which points to about 21 December 2026.
That date is a norm, not a deadline. The Commission usually follows the committee, but its decision is a separate legal act. A licence also puts nothing on a pharmacy shelf: the EMA states that pricing and reimbursement are then decided by each member state, so Foundayo will reach EU patients at different times country by country. We found no EU launch date from Lilly in a primary source.
England runs on its own clock. NICE's appraisal of orforglipron for managing overweight and obesity, reference ID6516, is a standard single technology appraisal with PenTAG at the University of Exeter as external assessment group. Its project page lists a committee meeting on 10 November 2026 and an expected publication date of 27 January 2027.
Some press coverage spoke of preliminary guidance in mid-November. NICE lists a meeting on 10 November, not a publication, and any draft recommendations would follow it. A separate appraisal for obstructive sleep apnoea associated with obesity is awaiting development, with no timeline.
What industry readers should watch
Most of what regulatory and market access teams need is not yet public. When it appears, the European public assessment report will show which studies the CHMP relied on for the weight indication, how it weighed the two estimands, and whether it asked for further safety data. Warnings and interactions, which the summary only points to, will be set out in the product information.
Three items will settle the open questions. First, the European Commission decision and EU register entry, expected around 21 December 2026. Second, the EPAR. Third, the NICE committee outcome after 10 November, which decides whether NHS patients in England can be offered orforglipron at all, and for which BMI band.
Suspected side effects with any GLP-1 medicine in the UK can be reported through the MHRA Yellow Card scheme. This report covers regulatory status and published trial data for an industry audience. Whether any person should take orforglipron is a decision for a prescriber.
What remains unknown is the comparison payers will ask for. ATTAIN-1 was placebo-controlled, and no peer-reviewed trial we could find sets orforglipron against an injectable GLP-1 for weight. On glucose, the EMA's ranges overlap with oral semaglutide. CHMP reasoning becomes visible only in the EPAR, after the Commission decides, and long-term safety beyond 72 weeks rests on the ATTAIN-1 extension, which runs to October 2027.
Next on the calendar: the NICE committee on 10 November 2026, then a Commission decision on Foundayo expected around 21 December 2026.
