FDA approves Praluent (alirocumab) for limited use in hypercholesterolemia - Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses (75 mg and 150 mg).

Comment: The FDA approval did not extend to all statin intolerant patients due to concerns of overuse of the drug which has yet to prove its long term worth once it reaches the wider market beyond clinical trials. Praluent is likely to be joined in the US by Repatha (evolocumab) from Amgen whose approval date is 27 August 2015 and later by bocicizumab from Pfizer which is still in Phase III trials.

Comment: Repatha was EU approved last week and Praluent has a CHMP recommendation. European regulators have granted an indication that extends to statin intolerant patients in contrast to the US.