THOUSAND OAKS (dpa-AFX) - Amgen, Inc. (AMGN) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha, or evolocumab, recommending approval for use in certain patients with high cholesterol.
Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 or PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or 'bad' cholesterol, from the blood.
The CHMP positive opinion will now be reviewed by the European Commission or EC, which has the authority to approve medicines for the European Union. The CHMP opinion is based on data from about 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials.
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