Foundayo EU Approval CHMP: What the EMA Opinion Means
Medically reviewed by Dr. Michael Teplitsky, MD Last reviewed 2026-10-17
An explainer on the European Medicines Agency recommendation, trial outcomes, and next steps for European Commission authorisation
Foundayo does not yet have an EU marketing authorisation. On 16 October 2026, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended granting an EU marketing authorisation for Foundayo (orforglipron), an oral glucagon-like peptide-1 (GLP-1) receptor agonist tablet for weight management and type 2 diabetes in adults. This recommendation is an intermediary step before the European Commission decision.
EMA clarified in its news release that the positive opinion is an intermediary step on Foundayo's path to patient access. The recommendation now moves to the European Commission for a decision on an EU-wide marketing authorisation, after which price and reimbursement are decided at Member State level.
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A CHMP opinion is a recommendation, not an authorisation. The CHMP adopted the opinion at its 12 to 15 October 2026 meeting. The meeting concluded with recommendations to approve six new medicines, with Foundayo listed among them in the EMA meeting highlights. The CHMP recommendation is an intermediary step on Foundayo's path to patient access. The opinion is sent to the European Commission, which decides on an EU-wide marketing authorisation. This page explains the regulatory process and is not medical advice. It does not cover US availability or US pricing. Anyone deciding whether a medicine suits them should talk to a licensed clinician.
What EMA Recommended Foundayo For
EMA recommended Foundayo for adult weight management and the treatment of type 2 diabetes. The marketing applicant is Eli Lilly Nederland B.V. EMA describes it as a once-daily tablet that provides an alternative to injectable and other oral GLP-1 receptor agonists.
For weight management, EMA recommends Foundayo alongside a healthy diet and physical activity. EMA recommends it for adults with obesity (BMI at least 30 kg/m2) or overweight (BMI at least 27 but below 30 kg/m2) who have at least one weight-related health problem.
For type 2 diabetes, EMA recommends use alongside a healthy diet and physical activity in adults whose blood glucose is not sufficiently controlled. It can be used alone when metformin is not appropriate, or together with other diabetes medicines.
Foundayo is an oral tablet taken once daily at any time of day, with or without food, and is available by prescription only. Treatment begins at a low dose that is gradually increased according to the patient's response and tolerance. Orforglipron is a small, non-peptide molecule that activates the GLP-1 receptor. GLP-1 is a natural hormone involved in controlling appetite and blood glucose. According to EMA, orforglipron reduces appetite, increases feelings of fullness, and lowers blood glucose by helping the pancreas release insulin during high glucose, reducing glucagon secretion, and helping the body respond better to insulin.
Study Results and Side Effects
EMA reports the following results from the studies it describes. For weight management, two clinical studies evaluated 4,740 adults with obesity or overweight. One trial enrolled adults without type 2 diabetes who had another weight-related health problem, while the second trial enrolled adults diagnosed with type 2 diabetes. After 72 weeks of treatment, patients taking Foundayo lost around 5% to 11% of their body weight depending on their dose, compared to a loss of around 2% to 2.5% among participants receiving a placebo.
For type 2 diabetes, four main clinical studies evaluated 3,765 adults with inadequately controlled blood glucose. Investigators evaluated Foundayo alone or combined with other diabetes therapies, testing it against placebo, dapagliflozin, and oral semaglutide. Across these trials, glycated haemoglobin (HbA1c) dropped by around 1.2 to 1.9 percentage points depending on the dose. By comparison, HbA1c fell by 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 7 mg and 14 mg doses.
| Indication | Participants Evaluated | Study Duration and Comparators | Reported Clinical Outcomes |
|---|---|---|---|
| Weight management | 4,740 adults with obesity or overweight | 72 weeks, compared with placebo | Weight loss of around 5% to 11% on Foundayo versus 2% to 2.5% on placebo |
| Type 2 diabetes | 3,765 adults whose blood glucose was not adequately controlled | Versus placebo, dapagliflozin, and oral semaglutide | HbA1c reduction of 1.2 to 1.9 points versus 0.4 to 0.8 (placebo), 0.8 (dapagliflozin), and 1.2 to 1.5 (oral semaglutide) |
According to EMA, the most common side effects are nausea, vomiting, and diarrhoea. These digestive symptoms occurred more often while the dose was being increased and became less frequent over time.
What Happens Next
Following the positive recommendation from the CHMP, the opinion is sent to the European Commission to adopt a decision on an EU-wide marketing authorisation. EMA notes that decisions about price and public reimbursement are taken at the level of each Member State.
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Frequently Asked Questions
Is Foundayo approved in the EU now that the CHMP gave a positive opinion?
Not yet. The positive opinion adopted by the CHMP at its 12-15 October 2026 meeting is an intermediary step. The European Commission must review the opinion and issue a formal decision regarding an EU-wide marketing authorisation. After a marketing authorisation is granted, price and reimbursement decisions are taken at the level of each Member State.
What is Foundayo and how does it work?
Foundayo (orforglipron) is a once-daily prescription tablet evaluated for weight management and type 2 diabetes. It is a small, non-peptide molecule that activates the GLP-1 receptor. According to EMA, orforglipron reduces appetite, increases feelings of fullness, and lowers blood glucose by helping the pancreas release insulin when blood sugar is elevated, reducing glucagon, and improving insulin responsiveness.
What are the recommended indications for Foundayo in Europe?
EMA recommended Foundayo for weight management alongside diet and physical activity in adults with obesity (BMI at least 30 kg/m2) or overweight (BMI from 27 to under 30 kg/m2) with at least one weight-related health problem. It is also recommended for adults with insufficiently controlled type 2 diabetes, either alone when metformin is unsuitable or combined with other diabetes medicines.
What are the most common side effects of Foundayo according to EMA?
The most common side effects according to EMA are nausea, vomiting, and diarrhoea. These effects occurred more often while the dose was being increased and became less frequent over time.
When will Foundayo be available in Europe?
EMA's announcement gives no date. The European Commission must first decide on an EU-wide marketing authorisation. After a marketing authorisation is granted, decisions about price and reimbursement are taken at the level of each Member State.
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