Posted by Michael Wonder on 22 Feb 2017
Repatha (evolocumab) receives European Commission approval for new 420 mg single-dose delivery option
21 February 2017 - Approval of the automated mini-doser marks first hands-free administration option for a PCSK9 inhibitor in Europe.
Amgen today announced that the European Commission has adopted a decision to change the Repatha (evolocumab) marketing authorisation, approving a new single-dose delivery option. The new automated mini-doser with a pre-filled cartridge is a hands-free device that provides 420 mg of Repatha in a single injection per administration. Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly injection.
Repatha is a human monoclonal antibody that blocks a protein called PCSK9, which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.
