UK is first European country to approve Lilly's Foundayo

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Eli Lilly's oral GLP-1 agonist Foundayo for weight management and type 2 diabetes.

The approval makes the UK the first country in Europe to approve Foundayo (orforglipron), which becomes 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 UK regulator has authorised Foundayo 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 can also be used to improve glycaemic control for patients with insufficiently controlled type 2 diabetes.

"We are pleased to be the first regulator in Europe to authorise this tablet for weight management and type 2 diabetes," said Julian Beach, the MHRA's executive director of healthcare quality and access.

"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," he added.

While now approved, making it an option for people with a prescription for Foundayo who are prepared to pay for it privately, 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. Sales in the second quarter ended 30th June came in at $98 million, lower than analyst expectations, but with a solid contribution from the UAE that analysts said is a strong indicator of the product's global potential.

While worldwide sales of first-to-market oral Wegovy pulled in almost $500 million in the same period, that figure also came in a little lower than expected.

"Having another oral treatment option expands choice, particularly for individuals who are reluctant to use injectable medicines or who may not require the degree of weight loss typically achieved with the most effective injections," said Naveed Sattar, professor of cardiometabolic medicine at the University of Glasgow.

"One advantage of orforglipron is its convenience. Unlike oral semaglutide, which must be taken fasting before food, it can be taken at any time of day, making treatment simpler for some people," he added.

"That said, oral semaglutide appears to deliver somewhat greater weight loss and, importantly, has proven cardiovascular benefits."