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FDA Approves Amgen’s Pushtronex System

New, single-use device developed in collaboration with West Pharmaceutical Services uses on-body infusor with prefilled cartridge to deliver monthly single dose of LDL cholesterol lowering Repatha.

New, single-use device developed in collaboration with West Pharmaceutical Services uses on-body infusor with prefilled cartridge to deliver monthly single dose of LDL cholesterol lowering Repatha.
New, single-use device developed in collaboration with West Pharmaceutical Services uses on-body infusor with prefilled cartridge to deliver monthly single dose of LDL cholesterol lowering Repatha.

Biotechnology company Amgen 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 PCSK9 that 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.

The new, single-use device was developed in collaboration with West Pharmaceutical Services, based on the SmartDose® technology platform, to provide patients with an additional dosing option for Repatha treatment. The device adheres to the body—usually on the abdomen—and patients are hands-free during administration. Patients are able to perform moderate physical activities (such as walking, reaching or bending) as the 420 mg of Repatha is delivered subcutaneously.

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