Eli Lilly GLP-1 pill Foundayo approved for obesity

The U.S. Food and Drug Administration has approved Eli Lilly‘s GLP-1 pill, the company said, a major milestone for the Indianapolis-based drugmaker and one that will test the market for new weight loss medications.

Lilly said the once-daily pill, Foundayo, will start shipping from direct-to-consumer platform LillyDirect on Monday and will be available at pharmacies and on telehealth platforms “shortly after.” People with insurance coverage could pay $25 a month with a coupon from Lilly, while people paying out of pocket could pay between $149 and $349, depending on the dose.

The approval comes just a few months after Lilly submitted the drug to the FDA as part of a program that grants speedy reviews for drugs that are considered national priority interests. That means Lilly will introduce Foundayo only about three months behind Novo Nordisk’s Wegovy pill, setting the stage for the next battle between the rival drugmakers in the next frontier for GLP-1 drugs.

“It’s a big moment,” Eli Lilly CEO Dave Ricks said in an interview with CNBC. “We’ve obviously been working in this category of medicines for a while with the first GLP-1 medication 20 years ago and improving ever since. Here is an option that’s not more effective … but it’s more accessible, it’s easier to fit into your daily routine.”

Lilly licensed the molecule, orforglipron, from Japanese drugmaker Chugai in 2018, paying just $50 million up front for global rights to the drug. But there are still questions about how big the drug will become. It doesn’t produce as much weight loss as Lilly’s best-selling shot Zepbound. Millions of people are already used to the routine of injecting themselves once a week.

Analysts estimate Foundayo sales will reach $14.79 billion by 2030, according to FactSet. That compares to expectations of $24.68 billion for the weight loss drug Zepbound and $44.87 billion for Mounjaro, which is marketed for diabetes in the U.S. and obesity and diabetes in the rest of the world.

Ricks said shots haven’t been as big of a barrier to uptake as Lilly once thought they would be. He still sees Foundayo as an attractive option for people who would rather take a pill or who are searching for a lower price than the injectables.

He sees it playing a role in maintenance, for people who achieve their goal weight with a shot and want to keep the weight off. And he sees Foundayo as a way to “reach the planet” without the manufacturing constraints or cold-chain requirements that come with Zepbound.

Foundayo is a small molecule whereas Zepbound and Wegovy are peptides, which require more intensive manufacturing processes, a barrier Ricks thinks will hinder generic versions of Wegovy that have recently launched in some other countries, including India.

“[Foundayo] does allow for scalability, and that will allow us to launch this globally on the first instance,” Ricks said. “So today, you can get the oral [Wegovy] in the…