Eli Lilly's Weight-Loss Pill Foundayo Wins First European Approval In Britain For Obesity Care Today

LONDON — Britain's medicines regulator authorized Eli Lilly's weight-loss pill Foundayo on Monday, making the United Kingdom the first country in Europe to approve the once-daily tablet for both weight management and type 2 diabetes.

The Medicines and Healthcare products Regulatory Agency, known as the MHRA, cleared the drug, known chemically as orforglipron, for use in adults with a body mass index of 30 or above, as well as for adults with a BMI between 27 and 30 who have at least one weight-related health condition, when used alongside a reduced-calorie diet and increased physical activity. The authorization also covers improving blood sugar control in adults whose type 2 diabetes is not adequately managed through other treatments.

Despite the approval, the regulator noted the tablet is not currently accessible through Britain's National Health Service. "Whilst this tablet is approved for use in the UK," the MHRA said in its announcement, decisions on NHS availability would follow the agency's standard evaluation process. That process includes a review by the National Institute for Health and Care Excellence, known as NICE, which is expected to publish its guidance on orforglipron for managing overweight and obesity on November 18.

A Lilly spokesperson told Reuters that Foundayo will launch in the UK later this month through private prescription. The spokesperson said the drug's private list price in the UK would undercut that of Mounjaro, Lilly's injectable weight-loss treatment, which currently lists for £330 for a month's supply, though the company did not disclose specific pricing details for the new pill.

Monday's approval marks the second oral GLP-1 medication cleared for use in the UK, following Novo Nordisk's approval for its Wegovy pill in June, intensifying competition between the two pharmaceutical giants in an increasingly crowded weight-loss drug market. That market has long been dominated by injectable therapies from both companies, though oral treatments are rapidly gaining ground even as injectables remain the market leaders due to their established efficacy and convenient once-weekly dosing schedules.

Henry Gregg, chief executive of the National Pharmacy Association, welcomed the approval, calling it "another significant day with a second weight-loss pill to be available." He said the development was particularly meaningful for patients who are unable or unwilling to use injectable medications, expanding the range of treatment options available to those seeking pharmacy-based care.

Clinical trial data submitted in support of the drug's approval showed meaningful results for patients. In the Phase 3 ATTAIN-1 trial, which enrolled more than 3,100 adults with obesity, participants who took the highest 36-milligram dose of orforglipron for 72 weeks lost an average of 11.2% of their body weight, compared with 2.1% among those who received a placebo. More than half of participants on the highest dose, 54.6%, achieved at least a 10% reduction in body weight. Results from the trial were published in the New England Journal of Medicine.

Orforglipron works by mimicking glucagon-like peptide-1, a hormone the body naturally releases after eating that acts on regions of the brain responsible for regulating appetite, helping patients feel fuller for longer while reducing hunger and food cravings. Treatment begins at a low dose of 0.8 milligrams and is gradually increased through several dose levels, up to a maximum of 17.2 milligrams, with patients generally spending at least one month at each dose level before advancing further. The most commonly reported side effects include nausea, constipation, diarrhea, vomiting, indigestion and abdominal pain.

Foundayo's primary advantage over its main rival lies in convenience. The pill can be taken once daily at any time, without restrictions around food or water intake. By contrast, Novo Nordisk's Wegovy pill must be taken on an empty stomach with a small amount of water, followed by a 30-minute wait before eating, drinking or taking other medications.

Foundayo's UK approval follows a swift authorization process in the United States, where the Food and Drug Administration ccleared the drug in April as part of a program designed to accelerate reviews of high-priority medications, completing its assessment of Lilly's application in roughly 50 days. Lilly Chair and Chief Executive David Ricks said at the time that the company believed Foundayo could help "level the playing field" for people living with obesity or weight-related complications, describing it as convenient, once-daily obesity care designed for real-world use. Since its U.S. launch, insured patients have been able to access the drug for between $149 and $349 per month depending on dosage.

The drug is also under active regulatory review in the European Union, where Novo Nordisk's Wegovy pill has already received a positive recommendation from the European Medicines Agency, with a final approval decision still pending from the European Commission. Foundayo has also secured approval in the United Arab Emirates, where regulators cleared the drug earlier this year, making the UAE the second country in the world, after the United States, to register the medication.

With both major GLP-1 drugmakers now racing to establish their oral treatments across international markets, Monday's UK approval further intensifies the competitive landscape between Lilly and Novo Nordisk, as both companies look to capture growing global demand for convenient, pill-based alternatives to their established injectable weight-loss and diabetes treatments.

This article discusses regulatory approval of a prescription medication and is intended for general informational purposes; anyone considering treatment for obesity or type 2 diabetes should consult a doctor or pharmacist about whether a specific medication is appropriate for their individual health needs.