EU approves Repatha (evolocumab) to treat uncontrolled cholesterol- Amgen

Amgen announced that the European Commission (EC) has granted marketing authorization for Repatha (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or 'bad' cholesterol, from the blood. Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood, and is recognized as a major risk factor for cardiovascular disease (CVD).

The EC approved Repatha for the following indications:

• treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
• treatment of adults and adolescents aged 12 years and over, with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapy.

The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.

Comment: Repatha will compete with several PCSK 9 inhibitors and in particular, Praluent (alirocumab) from Sanofi/Regeneron which is filed at the FDA and eventually RN 316 (bococizumab) from Pfizer, currently in Phase III trials, and later LY 3015014 from Eli Lilly and RG 7652 from Genentech/Roche which are both progressing through Phase II.