The FDA is requiring Eli Lilly to conduct extensive postmarketing studies for its newly approved GLP-1 pill Foundayo (orforglipron) to further assess potential safety risks.
The agency said additional data is needed to evaluate risks, including major adverse cardiovascular events, drug-induced liver injury and medullary thyroid cancer, as well as delayed gastric emptying associated with the therapy, according to an April 1 letter.
The approval includes multiple required studies and registries, including long-term monitoring of thyroid cancer risk for at least 15 years and a 10-year pediatric registry assessing growth, development and adverse events in patients treated for obesity.
Lilly must also complete pediatric trials, including a 72-week study in patients ages 12-17 and an 84-week study in patients ages 6-11, along with additional studies tracking pregnancy exposure and long-term outcomes.
The FDA approved Foundayo for adults with obesity or overweight with weight-related conditions based on data submitted Jan. 20, but said ongoing studies are needed to better define the drug’s long-term safety profile.
