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news.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 study found that Repatha significantly reduced the risk of major adverse cardiovascular events. Credit: H_Ko / Shutterstock.com.
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Repatha is intended for adults with established or high risk of atherosclerotic cardiovascular disease (ASCVD) and aims to reduce the risk by decreasing low-density lipoprotein cholesterol (LDL-C) levels, along with the management of other risk factors.
The recommendation is based on data from the Phase III VESALIUS-Cardiovascular (VESALIUS-CV) trial, which involved more than 12,000 patients.
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.
Results showed a 25% relative reduction for a composite of coronary heart disease death, myocardial infarction or ischaemic stroke, and a 19% decline in a broader composite endpoint that also included arterial revascularisations.
A 36% reduction in the risk of myocardial infarction was also reported.
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.
“The CHMP’s positive opinion reflects the strength of Repatha’s clinical evidence and brings us one step closer to making Repatha available to more patients who may benefit from it.”
In 2015, Repatha was initially approved in the EU for certain adults and paediatric patients with primary hypercholesterolaemia or mixed dyslipidaemia, as well as for reducing cardiovascular risk in adults with established ASCVD.
A final decision from the European Commission (EC) is expected in the coming months.
Burton added: “Repatha is the only PCSK9 inhibitor proven in a Phase III clinical trial to reduce the risk of a first major cardiovascular event. If approved by the EC, this expanded indication has the potential to redefine cardiovascular care for appropriate patients in Europe.”
Earlier this year, Amgen secured approval from the EC for Uplizna (inebilizumab) as an add-on treatment to standard therapy for adults with generalised myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
