EMA committee backs orforglipron (Foundayo) for weight management and type 2 diabetes

The study

This is a regulatory news item, not a clinical study. It summarises the meeting of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), held on 12-15 October 2026 and published on 16 October 2026. The committee recommended six new medicines for approval and five extensions of indication.

Three items matter most for diabetes and obesity care:

• Foundayo (orforglipron). The applicant is Eli Lilly Nederland B.V. The committee recommended a marketing authorisation for this oral GLP-1 receptor agonist for weight management and for treatment of type 2 diabetes in adults.
• Kyinsu (insulin icodec / semaglutide). The holder is Novo Nordisk A/S. The committee recommended an extension of indication for this medicine, which is already authorised in the European Union (EU).
• Fovlussea (ranibizumab). This is a new biosimilar, and the applicant is Accord Healthcare S.L.U. The committee gave it a positive opinion. Its recommended uses include visual impairment due to diabetic macular oedema and proliferative diabetic retinopathy.

What they found

The committee said Foundayo will be a tablet taken once daily. It described Foundayo as an alternative to injectable and other oral GLP-1 receptor agonists. The decision on Foundayo is pending from the European Commission (EC).

For Kyinsu, the highlights do not say what the new indication is. The EC decision is also pending.

For Fovlussea, the listed uses also include neovascular (wet) age-related macular degeneration, macular oedema secondary to retinal vein occlusion and choroidal neovascularisation. The EC decision is pending.

The highlights report no trial results, doses, efficacy data or safety data for any of these medicines.

How much weight to give it

A CHMP positive opinion is a recommendation. The highlights list "pending EC decision" for each product above, so the outcome is not final.

The highlights do not describe the evidence behind the opinions. They give no information on trial design, size, comparators or outcomes. Doctors should not draw conclusions from this item on how well Foundayo works, how safe it is or how it compares with other GLP-1 receptor agonists. That information will have to come from the full assessment documents and the published trials.

For your clinic

This news does not change practice by itself. The EU decision on Foundayo is still awaited, and Indian regulatory status is separate (see the India box). Please do not tell patients that an oral orforglipron option is available to them.

If patients ask about a new once-daily tablet, you can explain that a European committee has recommended it and that final decisions are awaited. Before using any new incretin product, read the full product information, the published trial papers and current guidelines.

The ranibizumab biosimilar opinion is relevant to eye care for people with diabetes. The highlights list its uses but give no dosing, efficacy or safety details; refer to the full product information once it is published.