FDA Demands More Safety Data for New Weight Loss Pill

The U.S. Food and Drug Administration (FDA) has asked Eli Lilly to collect further safety information on its newly approved weight loss pill, Foundayo. This request stems from the agency's assessment of potential risks, including heart-related issues like heart attack and stroke, and drug-induced liver injuries. The FDA also requires more data on the drug's effect on delayed stomach emptying.

Foundayo, which received approval this month under a fast-track pilot program, represents the second oral GLP-1 medication to reach the market. Injectable GLP-1 drugs, such as Novo Nordisk's Wegovy, carry a boxed warning for a rare risk of thyroid cancer, and the FDA is also asking Lilly to track this risk for Foundayo over at least 15 years.

Eli Lilly stated that the FDA's post-approval requirements are standard practice for ongoing safety reviews of newly authorized drugs. The company emphasized its commitment to patient safety and continuous monitoring of its medications. Experts note that such requests do not necessarily indicate a discovered safety problem but a need for more comprehensive long-term data, especially for newer active ingredients like orforglipron used in Foundayo.