Sanofi, Regeneron's PCSK9 inhibitor Praluent backed for European approval

The European Medicines Agency announced Friday that its Committee for Medicinal Products for Human Use (CHMP) recommended approval of Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor Praluent (alirocumab) to lower high levels of cholesterol in people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins. Earlier this week, the European Commission approved Amgen's PCSK9 inhibitor Repatha (evolocumab) for the treatment of patients with uncontrolled cholesterol who require additional intensive LDL cholesterol reduction.

The positive recommendation by the CHMP was supported by data from the findings of 10 Phase III studies involving more than 5000 patients. Study data published in March in the NEJM illustrated that Praluent, as well as Repatha, reduced LDL cholesterol levels by 60 percent and lowered the risk of cardiovascular events by about half.

Meanwhile, the FDA announced Friday the approval of Praluent for certain patients with high cholesterol, making it the first PCSK9 inhibitor cleared in the US. Specifically, the drug is indicated as an adjunct to maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol.

Last month, an FDA advisory committee recommended clearance of the therapy, although some panellists suggested that the drug should be limited to the treatment of certain patients, such as those with familial hypercholesterolaemia.

Moreover, the FDA is expected to render a final decision on whether to clear Repatha in August after an advisory panel backed approval of the drug in June. Analysts have estimated that Praluent and Repatha could each generate more than $2 billion in annual revenue by 2020.

For related analysis on the PCSK9 inhibitor class, see ViewPoints: Europe provides positive regulatory momentum for PCSK9 inhibitor class, but regional cardiologists likely to prescribe less than US counterparts. See also Spotlight On: How are PBMs preparing for the impending anti-PCSK9 bonanza? and ViewPoints: Label for newly approved Repatha in EU will have US payers holding their breaths.

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