Amgen announced that the Food and Drug Administration (FDA) has approved Repatha (evolocumab) Pushtronex system, an on-body infusor with a prefilled cartridge intended for once-monthly administration. 

Repatha Pushtronex is hands-free and delivers 420mg of evolocumab in a single dose. It is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) aged >13, who require additional lowering of LDL-C. 

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The Pushtronex device utilizes the SmartDose technology platform that provides patients with another dosing option for Repatha treatment. The single-use device adheres to the body and subcutaneously delivers the 420mg dose, allowing patients to participate in moderate physical activities (eg, walking, reaching, bending) while the drug is being delivered.

Repatha is already available as 140mg/mL strength single-use prefilled syringes and as single-use prefilled SureClick autoinjectors. The Pushtronex system will be available in early August.

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