Phase III Study of Repatha Achieves Endpoints in Coronary Artery Disease

A Phase III trial of Amgen’s Repatha met its primary and secondary endpoints, demonstrating positive effects on plaque buildup in coronary artery disease in patients already treated with optimized statin therapy, according to the company.

The placebo-controlled trial evaluated coronary atheroma volume, as determined by intravascular ultrasound, in 968 patients receiving optimized statin therapy and undergoing coronary catheterization. Patients were randomized to receive either monthly Repatha (evolocumab) 420 mg or placebo by subcutaneous injections. Amgen plans to present detailed results during the American Heart Association Scientific Sessions in November.

Repatha was approved in the U.S. in August 2015 for the treatment of high cholesterol or atherosclerotic heart disease in patients who require additional lowering of LDL-cholesterol.