FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi Wins EU Approval for Cholesterol-Lowering Drug

March 26, 2019
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Sanofi gained European approval for its cholesterol-lowering drug Praluent (alirocumab) after a successful Phase III trial.

The trial involving nearly 19,000 patients who had been diagnosed with a buildup of plaque in their heart valves, formally known as acute coronary syndrome—placing them at risk for heart attack or unstable angina. The trial showed that Praluent reduced the overall death rate by 15 percent.

The rights to Praluent are owned by Sanofi’s subsidiary, Regeneron. Last month, the companies announced that they are cutting the price of the blockbuster drug by up to 60 percent in the U.S.

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