Eli Lilly takes weight-loss pill battle global with first Foundayo approval outside U.S.

Eli Lilly has won its first approval to sell its weight-loss drug Foundayo outside the U.S., allowing it to compete with rival Novo Nordisk's Wegovy pill in the U.K.

It marks only the second GLP-1 weight-loss pill in the European market and comes just two months after Novo launched its Wegovy pill there.

The U.K.'s Medicines and Healthcare products Regulatory Agency said Monday that orforglipron, sold as Foundayo, will be available for weight management and type 2 diabetes on prescription. 

As with all new treatments, it will need to be evaluated for cost-effectiveness by the National Institute for Health and Care Excellence (NICE) to be available through the country's National Health Service.

Novo has used its months-long lead in the oral weight-loss space to position Wegovy pill in the market as the most effective oral option for losing weight.

Lilly has sought to emphasize that Foundayo can, as a small molecule medicine, be taken without any food restrictions. Wegovy must be taken first thing in the morning with a sip of water and no other food or drink for at least 30 minutes.

Foundayo has seen a significantly slower uptake in the U.S. than the Wegovy pill. Lilly CEO David Ricks told CNBC in April this was because it is a completely new medicine that needs time to establish itself with doctors and patients. 

This contrasts with the Wegovy pill, which uses the same active ingredient, semaglutide, as its injectable versions. 

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Foundayo launched in the U.S. in April and generated $98 million in sales for the second quarter.

Both companies say that weight-loss pills are expanding the market, rather than being bought only by people who'd already used the more expensive injectables.

"I could see a future where actually this market is, to a large extent, a pill market," Novo CEO Mike Doustdar told CNBC this month, while stressing it was still early days for Wegovy pill.

He pushed back on concerns that momentum was slowing after oral Wegovy sales came in slightly below some analyst forecasts in the second quarter.

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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 the pill.