Eli Lilly now has FDA approval for its GLP-1 obesity pill, introducing a convenient dosing alternative to injections and new competition to a Novo Nordisk weight loss pill that has experienced strong demand since its launch early this year.
The Wednesday regulatory decision for orforglipron covers use of this Lilly drug alongside diet and exercise as a way to reduce body weight and maintain weight loss. The approval covers adults with obesity or overweight who have at least one weight-related condition, such as obstructive sleep apnea or cardiovascular disease. Lilly will market the once-daily pill under brand name Foundayo.
The drugs that have shaped the obesity drug market to date are injectables. Novo Nordisk’s Wegovy targets the GLP-1 receptor while Lilly’s Zepbound targets both the GLP-1 and GIP receptors. Both are engineered peptides administered as weekly shots. In oral GLP-1 drugs, Lilly’s Foundayo has an advantage.
Novo Nordisk’s Wegovy pill is still a peptide that comes with the limitations associated with oral delivery of such drugs. Peptides aren’t easily absorbed in the gut, so Wegovy pill includes an ingredient that facilitates absorption. But this once-daily pill must be taken on an empty stomach with water; patients must not take anything else for the next 30 minutes. As an oral small molecule, Lilly’s Foundayo doesn’t have those restrictions. Taken with or without food, the Lilly drug still has the same effect.
The FDA review of Foundayo was based on two placebo-controlled Phase 3 studies that showed those who stayed on treatment with the highest dose through 72 weeks lost an average 12.4% of their body weight (about 27.3 pounds), results that were statistically significant and clinically meaningful. Factoring in those who discontinued treatment, the average was 11.1% loss in body weight, or about 25 pounds. Like other GLP-1 drugs, the most common side effects reported in Foundayo’s studies were gastrointestinal, such as nausea, constipation, and diarrhea. The warnings on Foundayo’s label are consistent with other products in the GLP-1 drug class.
Lilly said Foundayo will be available through LillyDirect, the direct-to-consumer website whose offerings include Zepbound. Prescriptions will be accepted immediately and the drug will begin shipping on April 6. Soon after, Foundayo will become more widely available through retail pharmacies and telehealth providers.
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigmaT, perceived complexity or the belief that their condition isn’t serious enough for treatment,” Lilly CEO David Ricks said in a prepared statement. “We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications.”
For eligible patients who have commercial insurance, Foundayo may cost as little as $25 a month, Lilly said. For those paying cash out of their own pockets, prices start at $149 per month for the lowest of the drug’s six dosage strengths. Starting July 1, eligible Medicare Pard D beneficiaries may be able to get the drug for $50 a month.
In a research note, UBS analyst Michael Yee said Lilly updated the price for the highest dose of Foundayo, which will now cost $349 a month — $50 less than what the company announced last fall when it struck a drug price deal with the Trump administration. These sums are all direct-to-consumer prices, which will be the largest channel until the drug becomes available through Medicare and payer and employer coverage starts. William Blair analyst Andy Hsieh said the lack of food restrictions for Foundayo gives it an edge over Wegovy pill. That advantage could help it blunt the strong market uptake of the Novo Nordisk drug, which launched in January.
“Overall, we continue to believe that injectable anti-obesity medications will retain the majority of market share (roughly 80%, based on our estimates) in the United States due to the high potency of injectables coupled with a more elevated U.S. [body mass index] population,” Hsieh wrote in a research note. “Based on initial feedback from the oral Wegovy launch, patients who are currently on oral GLP-1 receptor agonists are treatment-naive, suggesting the potential for the oral drug class to expand the [total addressable market].”
Foundayo represents the fifth approval for a drug awarded a Commissioner’s National Priority Voucher (CNPV), part of a pilot program that accelerates the review of products that address national health priorities. While standard FDA review can take 10 to 12 months, a voucher can shave the review period to one or two months. The FDA said it rendered its Foundayo verdict 50 days after Lilly filed the application for the drug. Without a voucher, the drug faced a Jan. 20, 2027 target date for an FDA decision.
Lilly said it has submitted orforglipron for regulatory review for weight management and/or type 2 diabetes in more than 40 countries.
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