FDA Approves First Cholesterol Lowering Device

by pharmacy on August 24, 2016

lower cholesterolIn July, the FDA approved the Repatha Pushtronex System. This is a single-dose delivery system that allows patients to receive 420 mg of the PCSK9 inhibitor in a single dose using SmartDose technology. The device should be available to consumers sometime in August.

Who can use it?

The device is designed to treat patients with HeFH, ASCVD, or HoFH. Heterozygous familial hypercholesterolemia (HeFH) is an underdiagnosed cardiovascular disease which affects approximately 1 in 500 people. This is an inherited condition that is passed on from the genetic information of one of the parents. Heterozygous familial hypercholesterolemia (HoFH) occurs when the genetic information of both parents who have the condition is passed on to a child. This is both a rarer and more serious condition, and can cause heart disease during childhood or the teen years. For both types of patients, the reduction of LDL cholesterol is imperative to long-term health and well-being.

Atherosclerotic Cardiovascular Disease (ASCVD) occurs when plaque builds along the walls of the arteries. This plaque is comprised of cholesterol, fat, calcium, and other substances. Over time it hardens and causes the passageway of the artery to narrow, thereby reducing blood flow to various parts of the body. This can lead to stroke, heart attack, and even death. Reducing the LDL levels in the patients who have ASCVD is one of the treatments for the condition.

What is Repatha?

Repatha is a medication designed to lower LDL cholesterol levels. It is not intended to be a cure for the above diseases, rather it is a component of treatment.  The manufacturer instructs it is to be used in addition to a proper diet and statin therapy. Pharmacists should effectively communicate this to patients. The device is priced at just over $14,000. However, the actual cost to patients is still undetermined as the initial price does not take into consideration discounts or reimbursements.

The device itself attaches to the body and allows free movement by the patient while the medication is being delivered. The subcutaneous injection can be delivered every two weeks in a 140mg dose or once per month in a 420mg dose. Previously, the medication had to be received in three consecutive injections.

The development of this type of device is a trend in medical technology that seeks to reduce the frequency with which medications must be received. Wearable technology and auto injectors have made great strides over the past decade and continue to evolve and offer an improved quality of life to the patients who are able to benefit from them.

 

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