PCSK9 Alirocumab Picks Up New European Indication

Patrice Wendling

March 18, 2019

The European Commission has approved the cholesterol-lowering medication alirocumab (Praluent; Sanofi/Regeneron) to reduce cardiovascular (CV) risk by lowering low-density-lipoprotein cholesterol (LDL-C) in adults with established atherosclerotic CV disease.

Alirocumab was the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the United States, after being cleared in July 2015 for lowering LDL-C in patients with heterozygous familial hypercholesterolemia or those at high CV risk who cannot lower their LDL-C with statins.

The new European indication is based on data from the ODYSSEY OUTCOMES trial in more than 18,000 patients who had experienced an acute CV event 1 to 12 months prior to enrollment and had an LDL-C of at least 70 mg/dL (1.8 mmol/L).

Participants also had to have a non-high-density-lipoprotein cholesterol level of at least 100 mg/dL (2.6 mmol/L) or an apolipoprotein B level of at least 80 mg/dL.

The study showed that the addition of alirocumab to high or maximally tolerated statins reduced both major CV events and all-cause death by 15% compared with placebo.

The greatest benefit from alirocumab was seen in patients with baseline LDL-C of at least 100 mg/dL versus those with lower LDL-C levels (P < .001 for the interaction between treatment and baseline LDL-C level).

Adverse events were similar between the alirocumab and placebo groups, except injection-site reactions (3.8% vs 2.1%).

"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," Jon Reed, MD, PhD, global head of research and development, Sanofi, said in a news release. "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 patients and physicians."

The ODYSSEY OUTCOMES data have also been submitted to the US Food and Drug Administration, with a target action data of April 28, 2019.

Alirocumab is available in two starting doses as a single 1 mL injection (75 mg and 150 mg) every 2 weeksl and also can be administered as a 300 mg dose once a month.

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