EMA CHMP 对 Eli Lilly 口服 GLP-1 药物 Foundayo（orforglipron）给出积极意见
Human medicines European public assessment report (EPAR): Foundayo, Orforglipron, Status: Opinion
2026 年 10 月 15 日，EMA 人用药品委员会（CHMP）通过积极意见，建议批准 Eli Lilly Nederland B.V. 的 Foundayo（orforglipron）上市，用于治疗 2 型糖尿病和体重管理。
CHMP 对 orforglipron 给出积极意见，读者可据此了解这款口服 GLP-1 在欧盟的适应症范围与常见不良反应。
Overview
On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Foundayo, intended for the treatment of type 2 diabetes mellitus and for weight management.
The applicant for this medicinal product is Eli Lilly Nederland B.V.
Foundayo will be available as 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg film-coated tablets. The active substance of Foundayo is orforglipron, a glucagon-like peptide 1 (GLP-1) receptor agonist (ATC code: not yet assigned). By means of its action on these receptors, orforglipron improves glycaemic control and aids weight management through several different mechanisms.
The benefits of Foundayo are its clinically relevant effect on glycaemic control in patients with type 2 diabetes. Foundayo has also a beneficial effect on body weight when used in combination with a healthy diet and physical activity. The most common side effects are gastrointestinal side effects such as nausea, vomiting and diarrhoea.
The full indication is:
Weight management
Foundayo is indicated as an adjunct to healthy diet and physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
- ≥ 30 kg/m2 (obesity), or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight- related comorbidity e.g. prediabetes or type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.
Type 2 diabetes mellitus
Foundayo is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to healthy diet and physical activity
- as monotherapy when metformin is considered inappropriate
- in combination with other medicinal products for the treatment of diabetes.
For trial results with respect to combinations, cardiovascular effects, effects on glycaemic control, and the populations studied, see sections 4.4, 4.5 and 5.1.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Product details
Name of medicine
Foundayo
Active substance
Orforglipron hemicalcium
International non-proprietary name (INN) or common name
Orforglipron
Therapeutic area (MeSH)
- Obesity
- Overweight
- Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10BJ
EMA product number
EMEA/H/C/006632
Marketing authorisation applicant
Eli Lilly Nederland B.V.
Opinion adopted
15/10/2026
Opinion status
Positive
来源：EMA New Medicine · ema.europa.eu