Sanofi/Regeneron’s LDL-Lowering Praluent Beats Competitor to U.S. Market

July 30, 2015

The FDA gave the green light to Sanofi and Regeneron’s cholesterol-lowering drug Praluent, beating Amgen’s Repatha in a race to be the first PCSK9 inhibitor in the U.S.

PCSK9 inhibitors work by blocking a particular protein which increases the number of receptors on the liver available to rid the blood of low-density lipoprotein, or bad, cholesterol.

Praluent (alirocumab) is approved for use in conjunction with diet and statin therapy in adults with heterozygous familial hypercholesterolemia or heart attack and stroke patients who require further lowering of LDL-C.

The approval was based on five placebo-controlled trials. Participants who took Praluent saw their bad cholesterol levels drop on average from 36 percent to 59 percent compared with placebo. A trial evaluating the effect of adding Praluent to statins on lowering cardiovascular risk is ongoing.

The approval comes just days after Repatha (evolucumab) was approved in the EU, where Praluent is awaiting consideration by a European Medicines Agency advisory panel.

The FDA’s Endocrinological and Metabolic Drugs Advisory Committee recommended Repatha in June for the same indications as Praluent. — Kellen Owings