The US Food and Drug Administration on Wednesday approved a second GLP-1 pill for weight loss, adding another option to its rapidly growing arsenal of obesity therapies.
The orforglipron pill, called Foundayo, is made by Eli Lilly, which also sells the GLP-1 drugs Zepbound for obesity and Mounjaro for diabetes. It is given as a weekly injection and, along with rival drugs Wegovy and Ozempic, has revolutionized weight loss and diabetes treatment, with millions of people taking the drug.
Foundayo came to market just months after the FDA approved the pill form of Novo Nordisk’s injectable obesity drug Wegovy. Both pills offer a new way to take GLP-1 drugs, named for the hormone they mimic that is important for appetite, digestion and insulin regulation. But Lilly says Foundayo represents progress because, unlike the Wegovy pill, it can be taken at any time and without restrictions on food and water.
“We really designed this to fit into people’s lives as easily as possible,” Dr. Dan Skovronsky, Lilly’s chief scientific and product officer, told CNN.
Wegovy pills should be taken first thing in the morning, 30 minutes before eating or drinking, which can interfere with absorption. That restriction doesn’t seem to have affected its popularity, though: It’s used by as many as 400,000 people in the U.S., according to estimates from Wall Street firm Mizuho.
The pill also represents a major change in price and access to GLP-1 drugs; in a deal struck with the Trump administration in November, Pills start at $149 a month in the lowest dose for patients to pay out of pocket, a lower price than previously available.
Lilly’s drug will cost as much as $349 out of pocket for the highest dose, still a hefty monthly amount for a drug designed to be taken long-term. Lilly said Wednesday that if patients refill their prescriptions within the 45-day window, the highest price would be $299 a month.
Patients whose insurance covers the drugs will likely have lower copays, and Lilly said Wednesday it will offer coupons to people with commercial insurance so they pay $25 a month.
As part of the Trump administration’s deal, Lilly said Medicare will also cover the pill for some patients, with a monthly copay of no more than $50, starting as soon as July 1.
“We really want to democratize obesity and overweight treatment for the millions of Americans who need it,” Skovronsky said.
He said Lilly estimates that fewer than 1 in 10 people who could benefit from a weight-loss drug take one of the injectable drugs and said the pill could appeal to people “with less severe obesity” who don’t want to try weekly injections.
Similar to other GLP-1 weight loss drugs, Foundayo is approved for people who are obese or who are overweight and have “weight-related medical problems,” such as high blood pressure.
In a trial supporting approval, people on the highest dose of Foundayo lost an average of 12% of their body weight over 72 weeks, compared to 0.9% for people taking a placebo. The injectable drug has produced weight loss in trials of more than 20%, while Novo Nordisk says the Wegovy pill has shown an average weight loss of up to 17% at the highest dose in trials.
Lilly has also tested what happens when people who have lost weight with injectable drugs switch to Foundayo, finding that it helps with weight maintenance. The study showed that patients who switched to the pill from the injectable Wegovy regained an average of 0.9 kilograms, or 2 pounds, while those who switched from Zepbound, which produced greater weight loss, gained an average of 5 kilograms, or 11 pounds.
The most common side effects of Foundayo are similar to other GLP-1 drugs: nausea, constipation and other gastrointestinal effects. Some people also experience hair loss.
Foundayo is approved for adults only and its safety and efficacy have not been established for children. Lilly also stated that the safety of the drug has not been established during pregnancy, and that people taking birth control pills should talk to their doctors about the possibility of starting other methods of prevention because birth control pills do not work as well while patients are taking Foundayo.
Lilly said the drug will be available for free home delivery via its LillyDirect platform starting April 6, with wider availability via pharmacies and telehealth providers shortly thereafter.
Novo Nordisk has also explored a new price and access structure for Wegovy, Tuesday unveiling a subscription offer for between $249 and $329 a month out of pocket. It also offers a price of $149 for the lowest dose of the Wegovy pill, but – as with all GLP-1 drugs – most patients switch to higher doses over time.
The FDA said Wednesday that it reviewed Foundayo’s application in just 50 days under the Commissioner’s National Priority Voucher pilot program, making it the fastest approval for a new molecular entity since 2002. Normally, new drug approval takes at least six to 10 months.
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