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Repatha Pushtronex System, a single monthly injection for PCSK9 inhibitor, approved by FDA


The FDA ( Food and Drug Administration ) 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 low-density lipoprotein cholesterol ( LDL-C ) from the blood.
Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.

In the U.S., Repatha is 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 ) over age 13, who require additional lowering of LDL-C.
The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

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 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.

Evolocumab is a human monoclonal antibody that binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein ( LDL ) receptor ( LDLR ), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface.
By inhibiting the binding of PCSK9 to LDLR, Evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for cardiovascular disease.
In the U.S., there are approximately 11 million people with ASCVD and/or familial hypercholesterolemia ( FH ) who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.
Familial hypercholesterolemia is caused by genetic mutations that lead to high levels of LDL-C at an early age. It is estimated that one million people in the U.S. have familial hypercholesterolemia, yet less than one percent are diagnosed. ( Xagena )

Source: Amgen, 2016

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