Praluent findings not strong enough to stop cardiovascular trial early, DMC says

An independent data monitoring committee (DMC) has recommended the continuation of the Odyssey Outcomes trial of the cholesterol-lowering drug Praluent (alirocumab) in high-risk cardiovascular patients.

French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) are trialling the drug in patients who had experienced a heart attack or unstable angina requiring hospitalization within a year of entering the trial, and were unable to control their low-density lipoprotein (LDL) cholesterol despite receiving maximally-tolerated statins and potentially other lipid-lowering therapies.

There was a chance that the 18,000-patient trial could end early if Praluent showed outstanding efficacy at the interim stage, but the DMC’s second pre-specified interim analysis has led to a recommendation that the study go on.