UK MHRA authorises orforglipron private prescription
Eli Lilly has announced that orforglipron (Foundayo), its oral glucagon-like peptide-1 (GLP-1) receptor agonist, is now available to be prescribed for eligible adults via private prescription following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday 10th August 2026.
Lilly is working with the National Institute for Health and Care Excellence (NICE) on the assessment of orforglipron for potential use on the NHS in England.
Orforglipron received marketing authorisation for two indications. Firstly, as an adjunct to a reduced-calorie diet and increased 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.
Additionally, Lilly has marketing authorisation for orforglipron in the treatment of adults with insufficiently controlled type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, both as monotherapy or in combination with other medicinal products for the treatment of diabetes.
The marketing authorisation is based on results from six clinical trials: ATTAIN-1 and ATTAIN-2 in weight management, and ACHIEVE-1, ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 in type 2 diabetes.
Khalil Asmar, vice president of cardiometabolic health for Lilly Northern Europe, commented: “The UK is the first country in Europe where Foundayo is now available. We’re pleased that this means there is another oral treatment option for eligible UK patients alongside licensed injectable treatments.”
Earlier this month, the UK became the first country to approve Foundayo, only the second product in the oral GLP-1 class to be cleared for use by the MHRA after Novo Nordisk's Wegovy (semaglutide) pill, which got the green light – for weight loss only – in June.
The drug has not yet gone through the appraisal process that would allow it to be made available via the NHS. Reimbursement authority NICE is currently working through the evaluation process, with a provisional date for preliminary guidance on its use for overweight and obesity in mid-November.
Foundayo is only commercially available in the US and United Arab Emirates (UAE) so far, having been approved by the FDA in April, and the UK is thought to be only the third country to clear it for marketing worldwide.
