Posted by Michael Wonder on 11 Jul 2016
FDA approves first and only single monthly injection for a PCSK9 inhibitor
10 July 2016 - Repatha (evolocumab) Pushtronex system available to U.S. patients in early August.
Amgen today announced that the U.S. FDA has approved the Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose.
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. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.
