FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi, Regeneron Win Expanded Label for Praluent

May 3, 2019
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Federal regulators have approved Sanofi’s and Regeneron’s request to expand the label for their cholesterol-blocking drug Praluent (alirocumab).

Praluent has been on the market since 2015 but its sales have been squeezed by Amgen rival Repatha (evolocumab). Now, Praluent is available to help prevent heart attacks, strokes and unstable angina—something Repatha can’t claim.

The expanded approval follows results from a Phase III trial of 18,924 patients. The trial found that patients in the Praluent group had 15 percent lower risks for major cardiovascular events overall, 27 percent lower risks of strokes, 14 percent lower risks for non-fatal heart attacks and 39 percent lower risks of being hospitalized for unstable angina. Praluent also showed a 15 percent lower chance of death overall for its patients.

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