FDA Approves Foundayo: Eli Lilly’s Oral GLP-1 for Weight Loss

The U.S. Food and Drug Administration (FDA) has approved Foundayo™ (orforglipron), a once-daily oral medication developed by Eli Lilly and Company, for adults struggling with obesity or those who are overweight and have weight-related medical problems. This approval marks a significant milestone as Foundayo is the only glucagon-like peptide-1 (GLP-1) receptor agonist available in pill form.

What is Foundayo and How Does it Work?

Foundayo, or orforglipron, belongs to a class of drugs known as GLP-1 receptor agonists. These medications work by mimicking the effects of the naturally occurring GLP-1 hormone, which plays a role in regulating appetite and food intake. By activating GLP-1 receptors in the brain and gut, Foundayo can help individuals feel fuller for longer, leading to reduced calorie consumption and potential weight loss.

How Effective is Foundayo?

While Foundayo offers the convenience of a pill, it’s important to note that it isn’t as effective for weight loss as Lilly’s weekly injection, Zepbound. Phase 3 clinical trial data showed that Foundayo helped people lose 12 pounds. Although, Eli Lilly CEO Dave Ricks emphasizes that the pill’s accessibility and ease of integration into daily routines make it a valuable option for many.

Availability and Cost

Foundayo will be available through LillyDirect, starting Monday, and will soon be accessible at pharmacies and telehealth platforms. The cost of Foundayo will vary depending on the dosage and insurance coverage. With a coupon from Lilly, individuals with insurance may pay around $25 per month. For those paying out-of-pocket, the price ranges from $149 to $349 per month.

Foundayo vs. Novo Nordisk’s Wegovy Pill

The FDA approval of Foundayo comes shortly after Novo Nordisk’s oral Wegovy received approval, setting the stage for competition in the oral GLP-1 market. Foundayo differs from Wegovy in that it can be taken at any time of day without meal restrictions, while Wegovy must be taken on an empty stomach each morning.

What’s Next for Eli Lilly?

Eli Lilly is also developing another GLP-1 medication, retatrutide, which has demonstrated even greater weight loss potential in clinical trials. The company licensed the molecule for Foundayo, orforglipron, from Japanese drugmaker Chugai in 2018.