Foundayo Oral GLP-1 Tablet Gets Positive EU Opinion
October 19, 2026
EMA’s human medicines committee, the CHMP, has recommended a marketing authorisation for the Foundayo oral GLP-1 tablet, a once-daily tablet containing orforglipron. The opinion, adopted on 15 October 2026, covers weight management and type 2 diabetes in adults. The applicant is Eli Lilly Nederland B.V. The European Commission makes the final decision, normally within 67 days.
Foundayo oral GLP-1 tablet trial results
In weight management, two studies involving 4,740 adults showed participants lost around 5% to 11% of their body weight after 72 weeks, depending on dose, against 2% to 2.5% on placebo. In type 2 diabetes, four main studies involving 3,765 adults showed HbA1c reductions of 1.2 to 1.9 percentage points, compared with 0.4 to 0.8 on placebo. The most common side effects were nausea, vomiting and diarrhoea, mostly during dose increases. Treatment starts at a low dose and is raised according to response and tolerance.
Why it matters
For payers, the open question is where Foundayo sits against injectable and existing oral options. The EMA compared it with dapagliflozin and oral semaglutide, which gives HTA teams a reference point for weighing price against an HbA1c gain of this size. Patients who decline injections may find a daily tablet useful. Our earlier report on orforglipron covers the regulatory route, and the economic burden of obesity in Europe sets the wider cost context.
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