Another GLP-1 weight loss pill gets FDA approval, and it has fewer restrictions on how it’s used
The US Food and Drug Administration on Wednesday approved the second GLP-1 pill for weight loss, adding another option to a 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. Those are given as weekly injections and, along with rival drugs Wegovy and Ozempic, have transformed weight-loss and diabetes treatment, with millions of people taking the medicines.
Foundayo is coming 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 medicines, so named for the hormone they mimic that’s important for appetite, digestion and insulin regulation. But Lilly says Foundayo represents an advance because, unlike the Wegovy pill, it can be taken at any time of day and without restrictions on food and water.
“We’ve 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.
The Wegovy pill must be taken first thing in the morning, 30 minutes before food or drink, which can interfere with its absorption. That restriction hasn’t appeared to affect its popularity, though: It’s already being used by as many as 400,000 people in the US, according to estimates from Wall Street firm Mizuho.
The pills also represent a major change in pricing of and access to GLP-1 drugs; in a deal struck with the Trump administration in November, the pills start at $149 a month at the lowest doses for patients paying out of pocket, a much lower price than had previously been available.
Lilly’s medicine will cost as much as $349 out of pocket for the highest doses, still a hefty monthly sum for a medicine designed to be taken long-term. Lilly said Wednesday that if patients refill their prescription within a 45-day window, the highest out-of-pocket price would be $299 a month.
Patients whose insurance covers the medicines will probably have much lower copays, and Lilly said Wednesday it will offer a coupon for people with commercial insurance so they may pay $25 a month.
As part of the Trump administration deal, Lilly said Medicare would 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 treatment of obesity and overweight for the millions of Americans that need it,” Skovronsky said.
He noted that Lilly estimates that fewer than 1 in 10 people who could benefit from a weight-loss medicine are taking one of the injectable drugs and said the pills might appeal to people who “have less severe obesity” who haven’t wanted to try a weekly shot.
Similar to the other GLP-1 weight loss drugs, Foundayo was approved for people with obesity 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 with 0.9% for people taking a placebo. The injectable drugs have produced weight loss in trials of more than 20%, while Novo Nordisk said the Wegovy pill showed average weight loss of up to 17% on the highest dose in trials.
Lilly has also tested what happens when people who’ve lost weight with an injectable medicine switch to Foundayo, finding that it helped with weight maintenance. The study showed that patients who switched to the pill from injectable Wegovy regained an average of 0.9 kilograms, or 2 pounds, while those who switched from Zepbound, which produced greater weight loss, regained an average of 5 kilograms, or 11 pounds.
The most common side effects for Foundayo are similar to those for other GLP-1 drugs: nausea, constipation and other gastrointestinal effects. Some people also experience hair loss.
Foundayo was approved for adults only and its safety and efficacy haven’t been established in children. Lilly also noted the drug’s safety hasn’t been established during pregnancy, and that people taking birth control pills should talk with their doctors about potentially starting another prevention method as birth control pills may not work as well while patients are taking Foundayo.
Lilly said the drug will be available for free home shipping via its LillyDirect platform starting April 6, with broader availability via pharmacies and telehealth providers shortly after.
Novo Nordisk has also explored new pricing and access structures for Wegovy, on Tuesday unveiling a subscription offering for between $249 and $329 a month out of pocket. It also offers the $149 price for the lowest doses of the Wegovy pill, but — as for all GLP-1 drugs — most patients move to higher doses over time.
The FDA said Wednesday it reviewed the Foundayo application in just 50 days under a Commissioner’s National Priority Voucher pilot program, making it the fastest approval of a new molecular entity since 2002. Typically, new drug approvals take at least six to 10 months.
