Eli Lilly announced on Apr. 16 that its drug Foundayo reduced cardiovascular events in people with type 2 diabetes, while showing no signs of liver safety issues in a recent clinical trial.
The announcement is significant because the U.S. Food and Drug Administration had recently flagged concerns about potential liver risks for Foundayo when used for obesity, requiring more data from ongoing studies.
In the phase 3 ACHIEVE-4 study, which included over 2,700 participants with type 2 diabetes who were overweight or obese, Foundayo lowered the risk of cardiovascular death, heart attack, stroke or chest pain hospitalizations by 16% compared to insulin glargine. The study also found a non-inferior risk of major adverse cardiovascular events versus insulin and reported a 57% lower risk of all-cause death for those taking Foundayo. A1C levels were also reduced by 16% compared to insulin during the year-long trial.
Analysts responded positively to these findings. Leerink Partners described the results as “outstanding,” while RBC Capital Markets said "the efficacy and safety profile support an approvable dataset." RBC analysts added: "This data should allay fears that Foundayo faces unique liver safety risks versus competitors like oral Wegovy... we view ACHIEVE-4 as a positive catalyst to refocus investors on Foundayo’s clinical profile."
Thomas Seck, senior vice president of product development for Lilly Cardiometabolic Health, said: "Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile." Seck added: "ACHIEVE-4 adds a new dimension to that evidence—cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk... we believe Foundayo could be an important new treatment option for people with type 2 diabetes."
Gastrointestinal side effects were most common in the study; up to 10.6% discontinued treatment due to these effects.
Foundayo was approved earlier this month for obesity under an FDA program designed to shorten review times for priority drugs. Eli Lilly plans to seek approval for diabetes using this same expedited process.
