Evolocumab recommended for approval in Europe

Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of the PCSK9 inhibitor evolocumab, recommending approval for use in certain patients with high cholesterol, according to a press release.

The committee recommended granting evolocumab (Repatha, Amgen) marketing authorization for the treatment of patients with primary hypercholesterolemia as an adjunct to diet. Evolocumab was recommended for administration in combination with a statin, with or without additional lipid-lowering therapies, among patients who were unable to achieve their target LDL with the maximum tolerated statin dose. Among statin-intolerant patients or those in whom statins are contraindicated, the committee recommended authorization for evolocumab alone or in combination with other lipid-lowering therapies, according to the release.

A recommendation was also made for use of evolocumab in addition to other lipid-lowering therapies among patients aged 12 years or older with homozygous familial hypercholesterolemia.

The positive opinion follows study results from the PROFICIO clinical trial program, which consists of approximately 6,800 patients across 16 phase 3 studies, including 4,500 patients with elevated cholesterol evaluated in 10 phase 3 trials. The program also includes five ongoing studies assessing the long-term safety and efficacy of evolocumab, as well as its impact on cognitive function and coronary atherosclerosis. The DESCARTES trial, which assessed evolocumab in patients with hyperlipidemia at risk for CVD, has already been published.

The European Commission will review the opinion and determine whether to approve the drug for use in 28 countries within the European Union. Members of the European Economic Area, including Norway, Iceland and Liechtenstein, will make corresponding decisions, according to the release.