MHRA (UK) approves orforglipron (Foundayo) for weight management and type 2 diabetes – Eli Lilly

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised orforglipron (Foundayo), making the UK the first country in Europe to approve this GLP-1 tablet for weight management and type 2 diabetes.

 

 

Alongside a reduced-calorie diet and increased physical activity, orforglipron is authorised for weight loss and weight maintenance in adults in the UK with a BMI of 30 or above, or a BMI of between 27 and 30, and at least one weight-related comorbidity. It is also authorised to improve glycaemic control for patients with insufficiently controlled type 2 diabetes.

Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said: “Following rigorous assessment of orforglipron’s safety, quality, and effectiveness, we are pleased to be the first regulator in Europe to authorise this tablet for weight management and type 2 diabetes.  As with all GLP-1 receptor agonists, this is a prescription-only medication, and the MHRA will keep the safety and effectiveness of orforglipron under close review.”

The orforglipron tablet is taken once daily and can be taken at any time of day with no food or water restrictions. Treatment begins at 0.8 mg, escalating through 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg, with a minimum of one month at each dose level. Orforglipron is a GLP-1 receptor agonist. It works by mimicking the action of a naturally occurring hormone, glucagon-like peptide (GLP-1), which is released by the body after eating. Orforglipron acts on areas of the brain that regulate appetite, helping people feel fuller for longer, reducing hunger and decreasing food cravings. As a result, it can help people eat less and support weight reduction alongside appropriate diet and lifestyle measures. In people with type 2 diabetes orforglipron also reduces the levels of sugar in the body when the levels of sugar are high.

The most common side effects for those taking orforglipron are nausea, constipation, diarrhoea, vomiting, dyspepsia (indigestion), and abdominal pain.

Whilst this tablet is approved for use in the UK, it is not available currently via the NHS. As with all new treatments, decisions on NHS use will follow established processes, including an evaluation by the National Institute for Health and Care Excellence (NICE).