Amgen’s Repatha receives positive EU opinion for expanded cardiovascular use

UK—Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) supporting an expanded indication for Repatha (evolocumab) to help prevent major cardiovascular events in high-risk patients before they experience a first heart attack or stroke.

The proposed indication covers adults with established or high-risk atherosclerotic cardiovascular disease (ASCVD).

Repatha lowers low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular disease, alongside other measures to manage cardiovascular risk.

The CHMP recommendation is based on findings from the Phase III VESALIUS-Cardiovascular (VESALIUS-CV) trial, which enrolled more than 12,000 adults at high cardiovascular risk who had not previously experienced a heart attack or stroke.

Trial demonstrates cardiovascular benefits

In the trial, researchers assessed whether adding evolocumab to standard lipid-lowering therapy could reduce the incidence of major cardiovascular events in this patient population.

The results showed that Repatha reduced the risk of a composite endpoint comprising coronary heart disease death, myocardial infarction and ischaemic stroke by 25% compared with standard therapy alone.

It also lowered the risk of a broader composite endpoint, which included arterial revascularisations, by 19%.

Furthermore, patients receiving Repatha experienced a 36% reduction in the risk of myocardial infarction, reinforcing the potential role of intensive LDL-C lowering in patients at high cardiovascular risk.

Amgen chief medical officer Paul Burton said many patients in Europe remain unable to achieve recommended LDL-C levels despite the availability of lipid-lowering treatments.

“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,” Burton said.

European Commission decision pending

The European Union initially approved Repatha in 2015 for certain adults and paediatric patients with primary hypercholesterolaemia or mixed dyslipidaemia.

The approval also covered cardiovascular risk reduction in adults with established ASCVD.

The European Commission (EC) is expected to make a final decision on the expanded indication in the coming months.

According to Burton, Repatha is the only PCSK9 inhibitor shown in a Phase III clinical trial to reduce the risk of a first major cardiovascular event.

If the EC approves the expanded indication, eligible high-risk patients across Europe could gain access to the treatment before experiencing a first heart attack or stroke.

Earlier this year, Amgen also secured EC approval for Uplizna (inebilizumab) as an add-on treatment to standard therapy for adults with generalised myasthenia gravis who test positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies