The U.S. Food and Drug Administration (FDA) approved Foundayo, a new oral medication for weight loss, on Wednesday, expanding the options available in the growing market of obesity therapies.

Second GLP-1 Pill Approved

Foundayo, developed by Eli Lilly, is the second GLP-1 pill to receive FDA approval. Eli Lilly also manufactures Zepbound for obesity and Mounjaro for diabetes, both administered as weekly injections. These medications, alongside Wegovy and Ozempic from Novo Nordisk, have significantly impacted the treatment of weight loss and diabetes, with millions of patients utilizing them.

Foundayo’s Advantages

Unlike the Wegovy pill, Foundayo doesn’t require timing with meals or restrictions on food and water intake. “We’ve really designed this to fit into people’s lives as easily as possible,” stated Dr. Dan Skovronsky, Lilly’s chief scientific and product officer, to CNN. The Wegovy pill must be taken first thing in the morning, 30 minutes before consuming anything, which can affect absorption.

Pricing and Access

The approval of these pills marks a shift in the pricing and accessibility of GLP-1 drugs. A deal with the Trump administration in November set the starting price for the pills at $149 a month for the lowest doses for cash-paying patients, a reduction from previous costs.

Foundayo will cost up to $349 per month out-of-pocket at the highest doses, with a reduced price of $299 for those refilling prescriptions within a 45-day window. Lilly will also offer a coupon for those with commercial insurance, potentially lowering the cost to $25 a month. Medicare coverage with a copay of no more than $50 per month will begin as early as July 1.

Expanding Treatment Options

Lilly estimates that fewer than 1 in 10 individuals who could benefit from weight-loss medication are currently using injectable drugs. Skovronsky believes the pill form may appeal to those with “less severe obesity” who haven’t considered injections.

Clinical Trial Results

Foundayo was approved for individuals with obesity or who are overweight and have weight-related medical conditions, such as high blood pressure. In a clinical trial, participants taking the highest dose of Foundayo lost an average of 12% of their body weight over 72 weeks, compared to 0.9% for those taking a placebo.

Studies also showed that patients switching from injectable Wegovy to Foundayo regained an average of 2 pounds, while those switching from Zepbound regained an average of 11 pounds.

Side Effects and Availability

Common side effects of Foundayo are similar to other GLP-1 drugs, including nausea, constipation, and other gastrointestinal issues. Hair loss has also been reported. The drug is approved for adults only and its safety hasn’t been established in children or during pregnancy. Patients using birth control pills should consult their doctors about alternative methods, as their effectiveness may be reduced.

Foundayo will be available for free home shipping via LillyDirect starting April 6, with broader availability through pharmacies and telehealth providers shortly after. Novo Nordisk also recently unveiled a subscription offering for Wegovy, ranging from $249 to $329 per month.

Expedited Approval Process

The FDA reviewed and approved Foundayo’s application in just 50 days under a Commissioner’s National Priority Voucher pilot program, marking the fastest approval of a new molecular entity since 2002. Typical drug approvals take 6-10 months.