A GLP-1 weight loss pill, already on sale in the United States, has hit a regulatory snag.
The Food and Drug Administration has asked U.S. drugmaker Eli Lilly to collect more long-term safety data on its once-daily tablet Foundayo, according to an April 1 letter published by the FDA Tuesday.
The FDA approved the pill under its program to fast-track drugs using 72-week, Phase 3 trial data but still needs to look at years-long data to understand all of the potential risks.
At the heart of the request is whether taking Foundayo - made using a new active ingredient called orforglipron - could be linked to liver, heart and gastrointestinal problems.
“We have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events, drug-induced liver injury and exposure to [Foundayo] during lactation,” the FDA wrote.
Eli Lilly has until the end of April to complete that clinical trial and until July to submit a final report.
An Eli Lilly spokesperson told The Independent that “patient safety is Lilly’s top priority” and that the company actively monitors, evaluates and reports safety information for all its medicines.
“The FDA approved Foundayo based on its review of data from the ATTAIN clinical program, with post‑approval requirements consistent with the agency’s standard approach to ongoing safety evaluation of newly approved medicines,” the spokesperson noted. “No hepatic safety signals have been observed for Foundayo across the Phase 3 program to date.”
It’s unclear if the pill will need to be altered in the future, based on the additional trial requested by the FDA. Eli Lilly has already conducted shorter-term research in patients with obesity and type 2 diabetes who are at increased risk of cardiovascular problems.
Foundayo is the second GLP-1 pill to hit the U.S. market after Novo Nordisk’s Wegovy pill. The Wegovy pill was approved by the FDA in December.
The FDA did not request additional safety data on the Wegovy pill but its active ingredient, semaglutide, was first approved in 2017 and its effects have been tested more than orforglipron.
The majority of weight loss pills come with side effects such as nausea and muscle loss. Drugmakers hope to address those issues and are working on ways to improve the medications and stop patients from dropping them.
Phase 3 results shared by Eli Lilly showed significant weight loss for people taking Fundayo, which acts to suppress appetite similar to popular injectable drugs.
Adults taking the highest-approved dose of the pill solely to lose weight shed an average of 17.2 pounds over the course of 72 weeks, according to Eli Lilly. Patients taking the Wegovy pill lost around 3 percent more of their body weight on average, according to a recent Novo Nordisk trial.
Weight loss pills were designed to help expand access to GLP-1s and offer a less invasive method of taking the medications.
Drugmakers are also working to make their products more affordable. GLP-1 injectables cost thousands of dollars a month for people without insurance. Out‑of‑pocket prices for weight loss pills are generally lower than injections but may still cost hundreds of dollars.
The lowest dose Wegovy pill, 1.5mg, costs around $25 a month for patients who have insurance and $149 a month out-of-pocket. The price is the same for 0.8 milligrams of Foundayo, Eli Lilly said.
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