Britain's medicines regulator has approved a second oral weight-loss drug in as many months, authorising Eli Lilly's once-daily pill orforglipron, branded Foundayo, for weight management and type 2 diabetes — a decision that makes the UK the first country in Europe to license the tablet.
The Medicines and Healthcare products Regulatory Agency approved the drug on 10 August, for adults with a body mass index of 30 or above, or between 27 and 30 with at least one weight-related condition, to be used alongside a reduced-calorie diet and exercise. Unlike semaglutide tablets, which must be taken on an empty stomach with only a sip of water, Lilly says orforglipron can be taken at any time of day without food or water restrictions, since it is a small-molecule drug rather than a peptide.
In the company's ATTAIN-1 trial, participants without diabetes taking the highest, 36-milligram dose lost an average of 12.4% of their body weight over 72 weeks, using the measure that reflects results among people who stayed on treatment, compared with under 1% on placebo. Nearly 60% of participants on that dose lost at least a tenth of their body weight, and almost 40% lost at least 15%. In a companion trial among people with type 2 diabetes, the same dose produced average weight loss of roughly 10.5% alongside a 1.8 percentage-point drop in blood sugar marker HbA1c. The most common side effects were gastrointestinal — nausea, diarrhoea, constipation and vomiting — consistent with other drugs in the GLP-1 class.
Joining an already crowded field
Orforglipron is the second oral GLP-1 pill cleared in the UK this year, after the MHRA authorised a semaglutide tablet version of Novo Nordisk's Wegovy in June. Both pills work on the same gut hormone pathway as injectable treatments such as Wegovy and Eli Lilly's own Mounjaro, which have driven a surge in prescriptions for obesity and diabetes since their UK launches. The Pharmaceutical Journal reported that regulators and clinicians expect price, tolerability and supply to determine how the newly approved pills are prescribed against their injectable and rival oral counterparts.
Julian Beach, the MHRA's executive director of healthcare quality and access, said the tablet had "met the MHRA's rigorous standards of safety, quality and effectiveness." The agency said it would keep the drug's safety record under close review as it reaches more patients.
Foundayo is not yet available on the NHS. The National Institute for Health and Care Excellence, which decides which treatments the health service funds, is expected to issue its own appraisal of the drug later this year, a process that typically takes many months from the point of licensing. Until then, the pill will be available only through private prescription, with UK pricing not yet confirmed by Lilly.
