CHMP recommends a new 420 mg single-dose delivery option for Repatha (evolocumab) for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C).- Amgen
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha (evolocumab). The new automated mini doser (AMD) with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.
Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. If approved by the European Commission (EC), Repatha would be the first PCSK9 inhibitor in Europe with the option of a single monthly injection. Repatha was the first PCSK9 inhibitor to gain marketing authorization in Europe as an every-two-week or monthly dosing regimen on July 17, 2015 . Repatha AMD will be available in Europe during 2017 depending on reimbursement requirements.
The CHMP positive opinion follows FDA approval of the single 420 mg monthly injection option on July 11, 2016 , as the Repatha Pushtronex system (on-body infusor with prefilled cartridge).
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