Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke. The trial evaluated the effect of adding evolocumab to standard lipid-lowering therapy in adults at high risk but with no previous heart attack or stroke. It found that Repatha significantly reduced the risk of major adverse cardiovascular events. Amgen chief medical officer Paul Burton said: “There remains a significant unmet need in Europe, where many patients at high cardiovascular risk are unable to achieve recommended LDL-C levels despite available lipid-lowering therapies. If approved by the EC, this expanded indication has the potential to redefine cardiovascular care for appropriate patients in Europe.”