FDA approves second GLP-1 pill for weight loss
The US Food and Drug Administration approved the second GLP-1 pill for weight loss on Wednesday, introducing another option to a growing range of obesity therapies, reports BritPanorama.
The orforglipron pill, branded Foundayo, is developed by Eli Lilly, which markets the GLP-1 drugs Zepbound for obesity and Mounjaro for diabetes. These previous offerings are administered via weekly injections, effectively reshaping weight-loss and diabetes management; they are currently utilized by millions.
Foundayo’s launch follows the FDA’s recent approval of the pill version of Novo Nordisk’s injectable obesity drug Wegovy. Both options signify a new approach to consuming GLP-1 medicines, named after the hormone they replicate that plays a crucial role in appetite regulation, digestion, and insulin management. Eli Lilly emphasizes that Foundayo allows patients to take the medicine at any time of day, without any restrictions concerning food or water, marking a significant advancement compared to the Wegovy pill.
“We’ve really designed this to fit into people’s lives as easily as possible,” stated Dr. Dan Skovronsky, Lilly’s chief scientific and product officer.
The Wegovy pill is to be taken first thing in the morning, 30 minutes prior to any food or drink, a requirement that can disrupt its absorption. Nevertheless, its popularity remains unaffected; estimates suggest around 400,000 people in the US are currently using the drug, according to Wall Street firm Mizuho.
The advent of these pills is a notable shift in the pricing dynamics and access to GLP-1 drugs. In a deal made with the Trump administration in November, these new medications will start at a monthly cost of $149 for out-of-pocket patients, a significant reduction from previous prices.
Lilly has priced its medication at up to $349 for the highest doses, a considerable amount for a long-term treatment. However, if patients refill their prescriptions within a 45-day period, the out-of-pocket cost for the highest dose could be reduced to $299 monthly.
Patients with insurance coverage can likely expect lower copayments, and Lilly has announced plans to provide a coupon for individuals with commercial insurance, allowing them to pay as little as $25 each month.
As part of the arrangement with the Trump administration, Medicare will cover the pill for select patients, enabling copayments not exceeding $50 beginning July 1.
“We really want to democratize treatment of obesity and overweight for the millions of Americans that need it,” remarked Skovronsky.
He highlighted that Lilly estimates fewer than 1 in 10 people eligible for a weight-loss medication currently utilize the injectable alternatives, suggesting that the new pills could attract those with “less severe obesity” who are reluctant to undergo weekly injections.
In line with other GLP-1 weight loss pharmaceuticals, Foundayo is indicated for adults with obesity or those classified as overweight with associated medical conditions like high blood pressure.
Clinical trials demonstrated those on the highest dose of Foundayo achieved an average weight loss of 12% over 72 weeks. In contrast, those administered a placebo lost only 0.9%. While the injectable differences tend to surpass 20% in weight reduction, Novo Nordisk noted that the Wegovy pill led to a weight loss average of up to 17% at its maximum dose.
Lilly’s trials indicated that individuals who transitioned from injectable medications to Foundayo preserved their weight loss effectively. Patients switching from Wegovy regained an average of 0.9 kilograms, whereas those shifting from Zepbound, which facilitates greater weight loss, regained approximately 5 kilograms.
Common side effects of Foundayo are consistent with those of other GLP-1 treatments, including nausea, constipation, and gastrointestinal issues, with some users experiencing hair loss.
The drug has received approval solely for adults, and its safety and effectiveness remain unverified in pediatric populations and during pregnancy. Additionally, patients on birth control pills should consult healthcare providers, as the medication may impact the efficacy of contraceptives.
Starting April 6, Lilly will offer Foundayo through its LillyDirect platform for free home shipping, with broader availability expected shortly thereafter via pharmacies and telehealth providers.
Meanwhile, Novo Nordisk is also pursuing innovative pricing and access models for Wegovy, recently launching a subscription model priced at $249 to $329 monthly out of pocket. It matches the $149 for the lowest doses of the Wegovy pill, though many patients typically move to higher dosages over time.
The FDA noted that Foundayo’s application was reviewed in just 50 days thanks to a National Priority Voucher pilot program, marking the fastest approval for a new molecular entity since 2002. Typically, approvals for new drugs take a minimum of six to ten months.
