Europe's medicine committee gave Foundayo a thumbs-up for treating obesity and type 2 diabetes, a step that pushes the pill toward clearance in more major markets. That opinion now moves to the European Commission, which usually makes its call within roughly two months.
Foundayo, taken once daily, is also known as orforglipron. It won U.S. clearance in April after an expedited Food and Drug Administration review under a new program designed to speed access to drugs deemed national health priorities, and it secured UK approval in August. It is the second GLP-1 tablet authorized for weight loss after Novo Nordisk's oral Wegovy.
Ken Custer, president of Lilly's cardiometabolic unit, said the company is "working hard" to be ready to roll out in the 30-country bloc tied to a European approval. "This is an opportunity for Lilly to really dramatically expand the availability," he said, adding the company will pursue coverage by European health systems and may offer the pill via telehealth depending on the market.
Lilly's push contrasts with Novo Nordisk's slower European rollouts for Wegovy, currently available in Germany and the UK. Novo's oral pill is a peptide that requires large quantities of active ingredient to make, while Foundayo is a small molecule produced with manufacturing techniques common to mass-market drugs like blood pressure pills and statins. Foundayo does not require any food or water restrictions, in contrast to Novo's pill.
A late-stage study showed that those on the top dose of Foundayo lost about 11% of their body weight across 72 weeks, compared with roughly 2% on placebo. The pill is central to Lilly's strategy to widen its lead in obesity treatments and reach patients who favor tablets over injections.
Lilly's U.S. debut ran behind analyst expectations as prescribers and patients got comfortable with a new drug. The company has since ramped marketing, including an ad featuring Martha Stewart, which it says is lifting consumer awareness. Demand is building, according to U.S. business chief Ilya Yuffa; he noted that more than 30% of patients beginning a weight-loss pill are opting for Lilly's product. "We're starting to see some progress," he said in September. "And that's a marked improvement just in the last two months of new starts."
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Lilly has already launched in select international markets such as the UK and the United Arab Emirates, and it has filed for approval in roughly 40 countries. "As soon as we get approvals, our plan is to launch," Yuffa said.
"We have supply readily available. Our commercial teams are ready. And so it's just a matter of the timing of those approvals." By 11:40 a.m. in New York, Lilly's stock was higher by just under 1%.
The bottom line: a Europe-wide go ahead would expand Foundayo's addressable market and tilt share toward oral GLP-1s, with manufacturing simplicity a potential edge on supply. Watch for the Commission's decision and the pace of reimbursement wins to gauge how quickly this turns into revenue and diversification for your portfolio.
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