U.S. health officials have approved a new weight-loss pill developed by Eli Lilly. The Food and Drug Administration (FDA) granted expedited approval to orforglipron, a GLP-1 drug, on Wednesday.

What is Orforglipron?

Orforglipron, branded as Foundayo, mimics a natural hormone that regulates appetite and fullness. It functions similarly to popular injectable medications used for weight management. The FDA reviewed the application in a remarkably swift 50 days.

Clinical Trial Results

In a study involving over 3,000 adults with obesity, participants receiving the highest dose of orforglipron (36 milligrams) experienced an average weight loss of 11.2% – approximately 25 pounds – over 16 months. This contrasted sharply with the 2.1% weight loss (less than 5 pounds) observed in the placebo group, as reported in the New England Journal of Medicine.

Pricing and Availability

Eli Lilly anticipates Foundayo will begin shipping on Monday. Individuals with insurance may access the medication for as low as $25 per month using a Lilly discount card. Cash prices will range from $149 to $349 monthly, depending on the dosage.

Comparison to Other Weight-Loss Treatments

While Lilly’s injectable Zepbound results in a 21% average weight loss and Novo Nordisk’s Wegovy averages 15%, Foundayo offers the convenience of a pill. Unlike Wegovy, which requires specific timing with water and an empty stomach, orforglipron has no such restrictions.

The study also indicated improvements in waist circumference, blood pressure, triglyceride levels, and cholesterol levels among orforglipron users. However, between 5% and 10% of participants discontinued treatment due to gastrointestinal side effects, compared to nearly 3% in the placebo group.

The pill will be included in a deal initiated during the Trump administration to lower prices on GLP-1 drugs. This aims to increase accessibility beyond those who can afford the current injectable options.

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