FDA asks Lilly for more safety data on weight loss pill Foundayo
The Food and Drug Administration is asking Eli Lilly to collect more data on the safety of its new diet pill, Foundayo, including whether it might be linked to liver and heart problems, according to the approval letter posted online Tuesday.
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Foundayo won FDA approval this month under the Commissioner’s National Priority Voucher, a pilot program intended to expedite drug review.
It is the second oral GLP-1 to hit the market in recent months, following the approval of Novo Nordisk’s Wegovy pill in December.
In the letter, the FDA said the data it has so far is not sufficient to fully understand several potential risks related to the drug, including heart problems such as heart attacks and strokes, as well as drug-induced liver damage. The agency also wants more data on delayed stomach emptying, which is when food stays in the stomach too long.
Injectable GLP-1s, like Wegovy and Zepbound, carry a boxed warning from the FDA about a rare risk of thyroid cancer. The agency also requires Lilly to collect data on thyroid cancer risk for at least 15 years.
In the approval letter for Novo Nordisk — the maker of the Wegovy pill — the FDA did not ask the company for additional data on liver or heart problems or thyroid cancer. The active ingredient in the Wegovy pill, semaglutide, however, was first approved in 2017 and has more safety data. Lilly’s drug uses a new active ingredient, called orforglipron.
Dr. Christopher McGowan, a gastroenterologist who runs a weight-loss clinic in Cary, North Carolina, said the FDA often asks drugmakers to collect more safety data after approval.
“That doesn’t mean a security issue has been discovered. It means they want more definitive long-term data,” McGowan said. “With orforglipron, it’s a newer, non-peptide version of GLP-1, so we don’t yet have the same depth of safety data as the injectables.”
A spokesperson for the Department of Health and Human Services, which oversees the FDA, did not immediately respond to a request for comment.
A Lilly spokesperson said in an emailed statement that the FDA’s post-approval requirements are routine and consistent with the agency’s approach to ongoing reviews of the safety of newly approved drugs.
“Patient safety is Lilly’s top priority and we actively monitor, evaluate and report safety information for all of our medicines,” the spokesperson said.
The agency said it also requires Lilly to conduct a series of new studies, including a registry tracking obese children who use weight-loss drugs and a pregnancy registry to monitor outcomes.
