EMA recommends Eli Lilly’s oral GLP-1 Foundayo (orforglipron) for weight management and type 2 diabetes
- CHMP recommended an EU marketing authorisation for Foundayo (orforglipron) for adult weight management and treatment of type 2 diabetes.
- In weight-management studies (>4,740 participants), Foundayo produced ~5–11% body‑weight loss at 72 weeks versus ~2–2.5% with placebo.
- In four diabetes trials (3,765 participants), Foundayo reduced HbA1c by ~1.2–1.9 percentage points versus 0.4–0.8 with placebo and compared with dapagliflozin and oral semaglutide.
- Foundayo is an oral, once‑daily, non‑peptide GLP‑1 receptor agonist tablet; common adverse events were nausea, vomiting and diarrhoea, especially during dose escalation.
Regulatory recommendation and indications
The CHMP has recommended granting an EU marketing authorisation for Foundayo (orforglipron), an oral GLP‑1 receptor agonist, for weight management and treatment of type 2 diabetes in adults. For weight management it is indicated with diet and physical activity for people with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to <30 kg/m2) with at least one weight‑related comorbidity. For type 2 diabetes it is indicated for adults whose blood glucose is not adequately controlled, as monotherapy when metformin is inappropriate or in combination with other diabetes medicines.
Drug profile and dosing
Orforglipron is a small, non‑peptide molecule that activates the GLP‑1 receptor to reduce appetite and lower blood glucose. It will be supplied as a once‑daily tablet that can be taken any time, with or without food, starting at a low dose which is gradually increased based on response and tolerability.
Clinical evidence
The weight‑management dataset comprises two studies with more than 4,740 adults; after 72 weeks Foundayo produced approximately 5–11% weight loss depending on dose versus about 2–2.5% with placebo. Diabetes efficacy derives from four main studies in 3,765 adults, showing HbA1c reductions of roughly 1.2–1.9 percentage points depending on dose, compared with 0.4–0.8 with placebo, 0.8 with dapagliflozin 10 mg and 1.2–1.5 with oral semaglutide (7 mg and 14 mg).
Safety and next steps
The most common adverse reactions were gastrointestinal (nausea, vomiting, diarrhoea), occurring more during dose escalation and becoming less frequent over time. The CHMP opinion will be sent to the European Commission for an EU‑wide decision; price and reimbursement decisions will follow at member‑state level if authorised.
Public‑health context
The recommendation comes against a backdrop of rising obesity and diabetes: more than 2.5 billion people are affected by overweight or obesity worldwide, excess body weight was associated with about 4 million deaths and 129 million DALYs in 2021, and roughly 589 million adults have diabetes, with type 2 accounting for ~90% of cases.
Source: EMA