UK approves Eli Lilly's Foundayo, Europe's second GLP-1 weight-loss pill
The U.K. clearance gives Foundayo its first European market, but NHS coverage depends on a pending cost-effectiveness review and private prescriptions come first.
Eli Lilly's Foundayo won its first European approval, when the U.K.'s Medicines and Healthcare products Regulatory Agency said orforglipron will be available by prescription for weight management and type 2 diabetes [1]. The pill, sold as Foundayo, is the second GLP-1 weight-loss pill on the European market, arriving about two months after Novo Nordisk launched its Wegovy pill in the U.K. [1].
Foundayo will initially be available privately by prescription in the U.K. [1]. Access through the National Health Service depends on a cost-effectiveness review by the National Institute for Health and Care Excellence, or NICE, which is standard for new treatments [1]. The agency did not disclose a timeline for that review [1].
The two companies are competing on how the pills are taken. Lilly emphasizes that Foundayo, a small-molecule medicine, can be taken without food restrictions [1]. The Wegovy pill must be taken first thing in the morning with a sip of water and no other food or drink for at least 30 minutes [1]. Novo has used its months-long head start in the oral market to position the Wegovy pill as the most effective oral option for weight loss [1]. The Wegovy pill uses semaglutide, the same active ingredient as Novo's injectable versions [1].
In the United States, Foundayo launched in April and generated $98 million in sales in the second quarter [1]. Lilly CEO David Ricks told CNBC in April that uptake had been significantly slower than the Wegovy pill because Foundayo is a completely new medicine that needs time to establish itself with doctors and patients [1].
Both companies say weight-loss pills are expanding the market rather than only being bought by people who already used the more expensive injectables [1]. Novo CEO Mike Doustdar told CNBC this month, "I could see a future where actually this market is, to a large extent, a pill market," while stressing that it is still early days for the Wegovy pill [1]. He also said that in the first three weeks the Wegovy pill was available in the U.K., around 300,000 patients were estimated to have started taking it [1]. He pushed back on concerns that momentum was slowing after oral Wegovy sales came in slightly below some analyst forecasts in the second quarter [1].
Why it matters for patients
U.K. patients now have two oral GLP-1 options, but the practical difference is payment. Foundayo starts on the private market, so patients there would pay out of pocket until NICE decides whether the NHS will cover it [1]. A NICE decision date has not been disclosed [1].
For people in the United States, this approval does not change what is available at home. Foundayo has been sold in the U.S. since April, and the Wegovy pill was already on the U.S. market before that [1]. The U.S. numbers show that a new pill does not automatically take hold quickly: $98 million in second-quarter sales for Foundayo compares with a faster start for the Wegovy pill, which contains a molecule patients and doctors already know from injections [1].
The U.K. pricing of Foundayo, whether insurers or employers in the U.S. will treat the two pills differently, and how the drugs compare head-to-head on weight loss have not been reported [1].
What happens next
The next milestone is the NICE cost-effectiveness review that would open NHS access in the U.K. [1]. No date for that review has been disclosed [1]. Which other European countries Foundayo will enter, and on what schedule, has not been reported [1]. Novo says it is still early for the Wegovy pill and that pill treatments are growing the overall market [1].
Sources
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