US pharma major Eli Lilly and Company announced on Wednesday that the US Food and Drug Administration has approved its new weight loss pill Foundayo. The company branded the new launch as the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. It is approved for adults with obesity or those overweight with weight-related medical conditions.
In a press release, Eli Lilly stated that Foundayo is designed to aid weight loss and maintenance when “used alongside a reduced-calorie diet and increased physical activity.” The pill is available via the company's LillyDirect platform, with shipping starting from April 6. It will soon reach US pharmacies and telehealth providers, the company said.
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"People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston.
"With Foundayo, we now have an oral option that delivers an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day,” Horn added.
What Is Foundayo?
The Lilly drug, orforglipron, will be sold under the brand name Foundayo. It is an FDA-approved drug for adults with obesity or those who have weight-related health problems. It is recommended to be taken along with a reduced-calorie diet and more physical activity.
It is a once-daily, non-peptide oral pill that can be taken any time of day, with no food or water restrictions. Orforglipron was discovered by Chugai Pharmaceutical Co Ltd. and was licensed by Eli Lilly in 2018. Lilly is also studying it as a possible treatment for type 2 diabetes and some other health conditions, the company stated.
What Trials Suggested?
According to Reuters, patients in trials taking Foundayo lost 12% to 15% of their body weight.
“In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.1 Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.2 In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, among others,” the company said in its press release.
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Price and Availability
Eli Lilly CEO David Ricks has said that the company has submitted the drug for approval in over 40 countries. This move puts Lilly in direct competition with Danish drugmaker Novo Nordisk in the global weight-loss market.
Lilly said it will sell Foundayo at a cost of $149 per month for the lowest dose for self-pay customers.
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