Amgen gets FDA approval for Pushtronex system for PCSK9 Inhibitor

12 July 2016 (Last Updated July 12th, 2016 18:30)

US-based medical device company Amgen has secured US Food and Drug Administration (FDA) approval for its Repatha (evolocumab) Pushtronex system which is an on-body infusor with prefilled cartridge.

US-based medical device company Amgen has secured US Food and Drug Administration (FDA) approval for its Repatha (evolocumab) Pushtronex system which is an on-body infusor with prefilled cartridge.

The Pushtronex system is a hands-free device which offers a single dose administration of 420mg of Repatha.

Repatha is a human monoclonal antibody acting as a proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitor.

Amgen research and development executive vice-president Sean Harper said: "The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients.

"Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration.

“The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide."

Developed in cooperation with West Pharmaceutical Services, the new, single-use device operates on the SmartDose technology platform which offers patients with an additional dosing option for Repatha treatment.

"The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide."

The SmartDose technology platform also enables self-administration by patients in accordance with their prescribed treatment.

The technology platform was built on extensive human factors testing and analysis to foster the interaction between the patient and the delivery system.

The device adheres to the anatomy and patients are hands free during administration.

The usage of the device does not interfere into the patient’s moderate physical activities such as walking, reaching or bending while subcutaneously delivering 420 mg of Repatha.


Image: Amgen’s Pushtronex system. Photo: courtesy of PRNewsFoto / Amgen.