MHRA approves second oral GLP-1, orforglipron, for weight loss
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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved orforglipron (Foundayo), for use in weight management and type 2 diabetes – making the UK the first country in Europe to do so.
It is authorised for weight loss and weight maintenance in adults 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.”
Henry Gregg, chief executive of the National Pharmacy Association said: "This is another significant day with a second weight loss pill to be available from some pharmacies in the near future.
“This is particularly significant for patients who cannot or do not want to take an injectable medicine and could make weight loss treatment available to a wider range of patients.
"However, there must now be a redoubling of efforts within government and the NHS to use pharmacies to make sure more eligible patients in clinical need can get this on the NHS, rather than the current postcode lottery that exists for weight management services via GPs.
“We are concerned that the NHS rollout remains extremely slow and community pharmacy is ready to support a wider rollout, which will help eligible patients access treatment safely and help mitigate the impact of obesity on the NHS.”
Foundayo has yet to be evaluated by the National Institute for Health and Care Excellence (NICE) and so is not currently available on the NHS.
Orforglipron: dosing and side effects
Orforglipron tablet is taken once daily. 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.
The most common side effects are nausea, constipation, diarrhoea, vomiting, dyspepsia, and abdominal pain.