Lilly Suspends Development of Heart Drug

Eli Lilly is suspending development of its leading heart drug candidate evacetrapib after an independent data monitoring committee determined it wasn’t effective in a Phase 3 clinical trial.

The drug was expected to be a blockbuster had it reached the market, and the decision to not move forward with it will cost Lilly up to $90 million, the company said.

The data monitoring committee recommended that the trial be stopped because evacetrapib wasn’t expected to meet its primary endpoint of reduced risk of heart attack and stroke. The drug was being evaluated for use in patients at high risk for atherosclerotic cardiovascular events. Lilly said the trial of 12,095 patients in 37 countries wasn’t halted for safety reasons.

This is the latest setback for a group of investigational drugs called cholesterol ester transfer protein inhibitors, which attempt to raise a person’s “good” cholesterol. Pfizer stopped a clinical trial of its CETP inhibitor torcetrapib in 2006 after the number of deaths in the torcetrapib plus Lipitor (atorvastatin) arm of the study exceeded those in the Lipitor-only arm. And in 2012, Roche halted a Phase 3 trial of dalcetrapib after an independent data monitoring board said the drug lacked clinically meaningful efficacy.

The only other CTEP drug, Merck’s anacetrapib, is in a Phase 3 trial that is expected to conclude in 2017. That drug has raised concerns as well, as it can stay in a patient’s blood for up to four years after treatment has ended, according to a study published in the American Journal of Cardiology in 2013. — Kellen Owings