CHMP recommends approval of Repatha (evolocumab) for high cholesterol-Amgen

The CHMP of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha (evolocumab), from Amgen, recommending approval for use in certain patients with high cholesterol.

The opinion is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase III trials. The Phase III studies evaluated the safety and efficacy of Repatha in patients with elevated cholesterol, including patients on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with HeFH; and patients with HoFH, a rare and serious genetic disorder.

The CHMP recommended granting Repatha marketing authorization for treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. In addition, 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, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. It is also recommended for the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.