礼来口服减肥药 Foundayo（orforglipron）获欧盟 CHMP 推荐批准，用于肥胖与2型糖尿病

Eli Lilly & Co.’s Foundayo won the backing of a key European regulatory panel, putting the weight-loss pill in line for approval in additional major markets.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the once-daily pill, also known as orforglipron, for obesity and type 2 diabetes on Friday, according to a statement. The recommendation now goes to the European Commission for a final decision, which typically follows within about two months.

Foundayo won US approval in April, becoming the second GLP-1 pill cleared for weight loss after Novo Nordisk A/S’s oral Wegovy. The Food and Drug Administration authorized the treatment after an expedited review, part of a new program aimed at accelerating access to medicines considered national health priorities.

The pill is an important part of Lilly’s strategy to expand its dominance in the booming obesity market and reach patients who prefer oral treatments to injections. Unlike Novo’s pill, Foundayo can be taken without restrictions on food or water.

In a late-stage clinical trial, patients taking the highest dose lost an average of about 11% of their body weight over 72 weeks, compared with roughly 2% for those receiving a placebo.

Foundayo’s initial US launch was slower than analysts expected, as doctors and patients got comfortable with an entirely new medication. Lilly has since ramped up its marketing, including a new advertisement with Martha Stewart, which is helping to drive more consumer awareness.

The company now sees demand increasing, according to US business chief Ilya Yuffa, who said more than 30% of patients newly starting a weight-loss pill are choosing Lilly’s drug.

“We’re starting to see some progress,” Yuffa said at an investor conference in September. “And that’s a marked improvement just in the last two months of new starts.”

Lilly has already launched in some international markets, including the UK and United Arab Emirates. It’s submitted Foundayo for approval in about 40 international markets, according to Yuffa.

“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.”