FDA Approves Single Monthly Injection of PCSK9 Inhibitor

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Repatha(R) (evolocumab) Pushtronex(TM) system (on-body infusor with prefilled cartridge); PRNewsFoto/Amgen
Repatha(R) (evolocumab) Pushtronex(TM) system (on-body infusor with prefilled cartridge); PRNewsFoto/Amgen

The US Food and Drug Administration has approved a new, monthly single-dose administration for evolocumab (Repatha®, Amgen, Inc), according to a press release from the manufacturer

The Pushtronex system™ (on-body infusor with prefilled cartridge) is a hands-free device designed to deliver 420 mg of evolocumab in a single dose. Currently, evolocumab is the only PCSK9 inhibitor to be offered as in a monthly single-dose form.

Evolocumab is indicated as an adjunct therapy to diet and maximally tolerated statin therapy for patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who need additional LDL cholesterol lowering, and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia in patients aged older than 13 years.

The device adheres to the patient's body, delivering the drug subcutaneously, which allows for simultaneous moderate physical activities (eg, walking, reaching, or bending).

The US Wholesale Acquisition Cost pricing of evolocumab is $14,100 per year; however, actual costs are expected to be lower since this pricing does not reflect rebates or discounts, according to information in the release.

The Pushtronex system™ will be available in the United States in early August 2016.

Reference

  1. FDA approves first and only single monthly injection for a PCSK9 inhibitor [news release]. Amgen Inc; Thousand Oaks, CA: July 11, 2016. Accessed July 11, 2016.
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