The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Foundayo on Wednesday, a once-daily oral medication for weight loss. This marks the second oral treatment authorized in the United States for obesity and associated health conditions.

What is Foundayo?

Foundayo, also known as orforglipron, is a GLP-1 drug that mimics a natural hormone regulating appetite and fullness. It’s a small-molecule GLP-1, meaning it can be taken as a pill without dietary restrictions. This differentiates it from other oral GLP-1 medications that require specific timing and fasting.

Clinical Trial Results

A clinical trial involving over 3,000 adults with obesity showed participants taking the highest dose (36 milligrams) of orforglipron lost an average of 11.2% of their body weight – approximately 25 pounds – over 16 months. This compared to an average loss of 2.1%, or less than 5 pounds, in the placebo group. Improvements were also observed in waist circumference, blood pressure, triglycerides, and cholesterol levels.

Expanding Access to Weight-Loss Treatment

Public health experts believe broader access to oral GLP-1 medications like Foundayo could significantly increase the number of people seeking medical treatment for obesity, which affects over 40% of U.S. adults. The pill format may be easier to adhere to than injections, and Eli Lilly’s pricing aims to improve affordability.

Pricing and Availability

Shipments of Foundayo are expected to begin Monday. With a discount card, insured patients may access the drug for as little as $25 per month. Cash-paying patients will see monthly costs ranging from $149 to $349, depending on the dosage.

How Foundayo Compares

Foundayo joins Novo Nordisk’s oral Wegovy, approved in December, in the oral GLP-1 market. While convenient, both oral pills have demonstrated less weight loss than their injectable counterparts. Lilly’s injectable Zepbound averages 21% weight loss, while Novo Nordisk’s Wegovy averages around 15%.

Unlike Novo Nordisk’s pill, Foundayo doesn’t require taking it with water on an empty stomach and waiting before eating or drinking.

Side Effects

Between 5% and 10% of participants taking orforglipron discontinued treatment due to gastrointestinal side effects, compared to nearly 3% in the placebo group. The FDA utilized a fast-track review program, approving the drug in just 50 days.

Approximately one in eight people in the U.S. have used injectable GLP-1 drugs, but high costs have limited access for many.