FDA Greenlights Eli Lilly’s GLP-1 Weight Loss Pill, Foundayo

The Food and Drug Administration (FDA) has approved a new weight loss medication developed by Eli Lilly. This pill, named Foundayo, is the second oral GLP-1 weight loss drug to enter the market, following Novo Nordisk’s Wegovy, which was approved in December.

Details About Foundayo

Foundayo will be available in six different doses. Patients are encouraged to start with the lowest dosage and slowly increase it to reduce potential side effects. Unlike Wegovy, which requires administration on an empty stomach in the morning, Foundayo can be taken at any time of day without food restrictions.

Cost and Coverage

The monthly cost for the lowest dose of Foundayo is projected to be around $149 for those paying out of pocket. Higher doses may reach up to $349 per month. Coverage by private insurers remains uncertain. However, a plan from the Trump administration indicates that Medicare could offer coverage for certain patients as early as this summer, with copays potentially as low as $50.

Eli Lilly’s CEO, Dave Ricks, emphasized the convenience of Foundayo, describing it as a straightforward oral medication that can easily fit into users’ daily routines.

Market Context and Effectiveness

This approval comes amidst significant growth in the GLP-1 market. Newer medications offer promising results, including higher weight loss and more affordable options. Eli Lilly is also working on another GLP-1 drug, retatrutide, which shows potential for greater weight loss than existing treatments.

• Phase 3 clinical trials indicated that Foundayo can result in an average weight loss of 12.4% for users at the highest dose over 72 weeks.
• This result is comparable to Wegovy but less effective than injectable drugs like Wegovy and Zepbound.

Dr. Jody Dushay, an endocrinologist at Harvard Medical School, remarked on the varying effectiveness of these pills. She noted that patients switching from injections to oral versions often experience lower weight loss results, stating, “12% is weak compared to what you’re going to see with Wegovy and Zepbound.”

Despite the differences, Ricks acknowledged the effectiveness of Zepbound but maintained that pills still have significant value. Many users prefer the convenience of pills over injections, which require refrigeration and weekly administration.

Patient Considerations

The demand for weight loss medications is robust, as evidenced by Novo Nordisk’s figures showing over 170,000 individuals using Wegovy since its launch. Dushay noted that pills like Foundayo might be suitable for those maintaining weight loss after using injectable options, as well as for patients who struggle with injection site reactions.

Foundayo’s side effects are reported to be similar to those of injectable GLP-1 medications, with gastrointestinal issues, including nausea, constipation, and diarrhea, being the most frequently observed.