CHMP recommends Praluent (alirocumab) for the treatment of hypercholesterolemia.- Sanofi+ Regeneron Pharma.

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).The CHMP has recommended Praluent in both a 75 mg and 150 mg dose be approved for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH] and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in patients unable to reach their low density lipoprotein cholesterol (LDL-C) goals with a maximally-tolerated statin. Praluent would be used in combination with a statin, with or without other lipid-lowering therapies; and b) for patients who are statin intolerant, or for whom a statin is contraindicated, Praluent would be used alone or in combination with other lipid-lowering therapies. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. The most common adverse reactions were injection site reactions, upper respiratory tract signs and symptoms, and pruritus.

Comment:The FDA has set a target action date of 24 July 2015 for the Biologics License Application (BLA) of Praluent.