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FDA Approves First Single Monthly Injection of PCSK9 Inhibitor
The FDA has approved the Repatha (evolocumab) Pushtronex system (Amgen), an on-body infusor with prefilled cartridge. The product provides a monthly single-dose administration option for evolocumab as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein-cholesterol (LDL-C), and as an adjunct to diet and other LDL-lowering therapies in patients more than 13 years of age with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
The Pushtronex system is a hands-free device designed to provide 420 mg of evolocumab in a single dose. Evolocumab is a human monoclonal antibody that blocks proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body’s natural system for eliminating “bad” cholesterol (LDL-C) from the blood. Evolocumab is the first PCSK9 inhibitor to be available as a monthly single-dose delivery option.
The effect of evolocumab on cardiovascular morbidity and mortality has not been determined.
The new, single-use device was developed by Amgen in collaboration with West Pharmaceutical Services, based on the SmartDose technology platform, to provide patients with an additional dosing option for evolocumab treatment. The device adheres to the body, and patients are hands free during drug administration. Patients are able to perform moderate physical activities (such as walking, reaching, or bending) as evolocumab (420 mg) is delivered subcutaneously.
The U.S. wholesale acquisition cost (WAC) of evolocumab is $14,100 annually, whether it is delivered monthly via the Pushtronex system or every two weeks via the SureClick autoinjector. Actual costs to patients, payers, and health systems are anticipated to be lower, as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on their insurance status and eligibility for patient assistance. The Pushtronex system will be available in the U.S. in early August.
Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the LDL receptor (LDLR), thereby 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.
Source: Amgen; July 11, 2016.