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UK becomes first European nation to approve oral GLP-1 drug orforglipron

UK's MHRA authorises orforglipron (Foundayo) for weight and diabetes, a European first. NHS availability pending NICE evaluation.

The United Kingdom has become the first country in Europe to approve orforglipron, a once-daily oral GLP-1 receptor agonist marketed under the brand name Foundayo. The Medicines and Healthcare products Regulatory Agency (MHRA) granted authorisation for the drug's use in weight management and for the treatment of type 2 diabetes.

The decision marks a significant step in expanding access to GLP-1 therapies, which have gained prominence for their dual role in glycaemic control and weight reduction. Unlike many existing injectable options in this class, orforglipron is administered as a tablet, potentially offering a more convenient alternative for patients.

However, the MHRA clarified that orforglipron is not currently available through the National Health Service (NHS). Any decision on NHS funding and routine prescribing will follow a separate evaluation by the National Institute for Health and Care Excellence (NICE), which assesses clinical and cost-effectiveness.

The regulator also stated that it will continue to closely monitor the safety and effectiveness of orforglipron as it enters use, ensuring ongoing vigilance in real-world settings.