GLP-1 Weight Loss Pill: The US Food and Drug Administration on Wednesday approved Foundayo, a new GLP-1 weight loss pill made by Eli Lilly, adding another option to the rapidly growing arsenal of obesity therapies.
The orforglipron pill, called Foundayo, is the second GLP-1 pill approved for weight loss, coming just months after the FDA greenlit Novo Nordisk's Wegovy pill.
Eli Lilly already sells the injectable GLP-1 drugs Zepbound for obesity and Mounjaro for diabetes. Together with rival drugs Wegovy and Ozempic, these medications have transformed weight-loss and diabetes treatment, with millions of people taking them.
How Is Foundayo Different From Other Weight Loss Pills?
Unlike the Wegovy pill, which must be taken first thing in the morning, 30 minutes before food or drink, Foundayo can be taken at any time of day 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's morning-only requirement hasn't appeared to affect its popularity, with an estimated 400,000 people already using it in the US, according to Wall Street firm Mizuho. However, Lilly says its pill offers greater flexibility for patients.
How Much Does Foundayo Cost?
Under a deal struck with the Trump administration in November, Foundayo starts at $149 a month for the lowest doses for patients paying out of pocket. The highest doses cost up to $349 monthly, though if patients refill within a 45-day window, the price drops to $299. Patients whose insurance covers the medicine will likely have much lower copays. Lilly is also offering a coupon for people with commercial insurance so they may pay $25 a month.
As part of the Trump administration deal, Medicare will cover the pill for some patients starting July 1, with a monthly copay of no more than $50. 'We really want to democratize treatment of obesity and overweight for the millions of Americans that need it,' Skovronsky said.
How Much Weight Do People Lose on Foundayo?
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. By comparison, injectable GLP-1 drugs have produced weight loss of more than 20% in trials, while the Wegovy pill showed average weight loss of up to 17% on the highest dose.
Lilly also tested what happens when people who've lost weight with injectable medicines switch to Foundayo. Patients who switched to the pill from injectable Wegovy regained an average of 2 pounds, while those who switched from Zepbound regained an average of 11 pounds.
GLP-1 Weight Loss Pill:What Are the Side Effects?
The most common side effects for Foundayo are similar to other GLP-1 drugs: nausea, constipation and other gastrointestinal effects. Some people also experience hair loss. The drug was approved for adults only, and its safety hasn't been established in children or during pregnancy.
Lilly noted 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.
GLP-1 Weight Loss Pill: Who Is Foundayo For?
Foundayo was approved for people with obesity or who are overweight and have 'weight-related medical problems,' such as high blood pressure. Lilly estimates that fewer than 1 in 10 people who could benefit from a weight-loss medicine are taking an injectable drug. Skovronsky said the pills might appeal to people who 'have less severe obesity' who haven't wanted to try a weekly shot.
How Can I Get a GLP-1 Weight Loss Pill?
The drug will be available for free home shipping via Lilly's LillyDirect platform starting April 6, with broader availability via pharmacies and telehealth providers shortly after. The FDA reviewed the 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.
FAQs: GLP-1 Weight Loss Pill
Q: What is Foundayo?
A: It's a GLP-1 weight loss pill made by Eli Lilly, approved by the FDA on Wednesday for obesity and overweight treatment.
Q: How much does Foundayo cost?
A: Out-of-pocket prices range from $149 to $349 monthly, with lower prices for refills. Medicare copays are capped at $50 starting July 1.
Q: How is it different from the Wegovy pill?
A: Foundayo can be taken at any time of day without food or water restrictions, unlike the Wegovy pill which requires taking it first thing in the morning on an empty stomach.
Q: How much weight can I lose?
A: In trials, patients lost an average of 12% of body weight over 72 weeks.
Q: What are the side effects?
A: Common side effects include nausea, constipation and other gastrointestinal issues. Some people experience hair loss.
Q: When will it be available?
A: Free home shipping via LillyDirect starts April 6, with pharmacies and telehealth providers following shortly after.
Disclaimer: This information is based on inputs from news agency reports. TSG does not independently confirm the information provided by the relevant sources.