A European medicines committee has recommended Foundayo, a once-daily tablet containing orforglipron, for adult weight management and type 2 diabetes. The positive opinion is a significant regulatory step, but it is not yet an EU-wide marketing authorisation.
The Committee for Medicinal Products for Human Use adopted its opinion on 15 October. It will now go to the European Commission, which makes the decision on whether to grant an EU marketing authorisation. Only after that decision would questions of price and reimbursement be considered separately by each member state.
Who the recommendation covers
For weight management, the recommendation covers adults using the medicine alongside a healthy diet and physical activity. It is intended for adults with obesity, defined here as a body mass index of at least 30kg/m², or for adults who are overweight with a body mass index from 27kg/m² to below 30kg/m² and at least one weight-related health condition.
The proposed type 2 diabetes use is also for adults, alongside diet and physical activity, when blood-glucose levels are not sufficiently controlled. The medicine could be used by itself when metformin is not appropriate, or with other diabetes medicines. These are proposed EU indications, not a description of a medicine already authorised for those uses across the bloc.
What the regulator’s evidence summary says
For weight management, the committee considered two studies involving 4,740 adults with obesity or overweight. One study enrolled people without type 2 diabetes who had another weight-related health problem; the other enrolled adults with type 2 diabetes. After 72 weeks, people taking Foundayo lost about 5% to 11% of their body weight, depending on dose. The comparable figure for placebo was about 2% to 2.5%.
Those are average results from the studies, rather than a prediction of what any one person will experience. The dose range is important: the regulator’s summary reports a spread of results rather than one single weight-loss figure for the tablet.
Four further main studies, involving 3,765 adults with type 2 diabetes, assessed blood-glucose control. Across those studies, the change in HbA1c — a measure used to monitor longer-term glucose control — was a reduction of roughly 1.2 to 1.9 percentage points, depending on dose. The studies included comparisons with placebo, dapagliflozin and oral semaglutide in different settings.
Tablet format and reported side effects
Orforglipron is a small, non-peptide molecule that activates the GLP-1 receptor, which is involved in appetite and blood-glucose regulation. The proposed tablet is taken once daily and may be taken with or without food. Treatment would begin at a low dose and be increased according to response and tolerability.
The most commonly reported side effects were nausea, vomiting and diarrhoea. The regulator said these effects were reported more often while the dose was being increased and became less frequent over time. Its assessment also sets out that use would be alongside diet and physical activity, rather than presenting the medicine as a substitute for them.
What happens next
The committee’s opinion is an intermediate stage in the EU process. The European Commission has not yet made the final marketing-authorisation decision, and no EU-wide launch date, price or reimbursement arrangement follows from the recommendation itself. National decisions on funding and use would remain separate even if an authorisation is granted.
The committee’s opinion belongs to the EU marketing-authorisation process. It is not a UK licensing decision.
