CV benefit claim added for Praluent in Europe

18 March 2019

The European Commission (EC) has approved a new indication for Praluent(alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors.

The PCSK9 inhibitor drug was developed by USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext SAN). Praluent competes in the market sector with Amgen’s (Nasdaq: AMGN) rival Repatha (evolocumab).

"Many patients with atherosclerotic cardiovascular disease often struggle to control their high LDL-cholesterol levels, despite lifestyle modifications and treatment with statins, and some have already experienced cardiovascular events," said Dr John Reed, global head of R&D at Sanofi, adding: "These patients could face a higher risk of another life-threatening cardiovascular event, and Praluent's new indication in Europe offers a risk-reduction focused lipid-lowering treatment option to physicians and patients."

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