FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi’s High Cholesterol Treatment Gets CHMP Nod

Feb. 11, 2019
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The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) handed Sanofi’s high cholesterol med Praluent (aliromucab) a positive opinion.

The committee’s recommendation is for a new indication to lessen cardiovascular risk by reducing low-density lipoprotein cholesterol (LDL-C) levels as an adjunct treatment to correction of other risk factors in adults with atherosclerotic cardiovascular disease (ASCVD).

“Praluent should be used in addition to maximally tolerated statins or can be used alone in patients intolerant to or inappropriate for statin therapy,” the CHMP said.

The opinion was based on data from a Phase 3 trial that assessed the drug’s effect on nearly 19,000 patients who had acute coronary syndrome between one to twelve months before trial enrollment.

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