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FDA Approves Medical Device For Monthly Injection Of PCSK9 Inhibitor



High levels of LDL cholesterol in the blood has been associated with a higher risk of cardiovascular disease.

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July 12, 2016 | by Sarah Massey, M.Sc.

The US Food and Drug Administration (FDA) has approved a new monthly, single dose medical device - called Pushtronex - for the infusion of the LDL cholesterol-lowering drug, Repatha. Marketed by Amgen, Repatha is a monoclonal antibody belonging to the PCSK9 inhibitor class of drugs.

The Pushtronex hands-free medical device consists of a pre-filled cartridge containing 420 mg of Repatha. Despite the availability of other PCSK9 inhibitors, Amgen is the first company to offer the biologic as a once-monthly treatment.

“The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients,” said Dr. Sean E. Harper, executive vice president of Research and Development at Amgen. “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.”

Repatha is approved in the US to treat LDL cholesterol-associated conditions, including heterozygous familial hypercholesterolemia (HeFH), clinical atherosclerotic cardiovascular disease (ASCVD) and homozygous familial hypercholesterolemia (HoFH). In some indications, it is used in combination with other cholesterol-lowering therapies, such as statins, and in conjunction with changes in diet.

Based on SmartDose Technology, Amgen developed the single-use medical device in collaboration with West Pharmaceutical Services. By offering an additional dosing option, patients are able to perform moderate physical tasks such as walking, while receiving their dose of Repatha subcutaneously.

According to Amgen, the U.S. Wholesale Acquisition Cost (WAC) of Repatha is $14,100 annually, however the company anticipates the patient and payer costs to be significantly lower. Amgen expects the Pushtronex system will be available to US patients as early as August.

High levels of LDL cholesterol in the blood has been associated with a higher risk of cardiovascular disease. Approximately 11 million people in the US have ASCVD and/or familial hypercholesterolemia (FH), which is not adequately controlled using traditional statin drugs or other cholesterol-lowering treatments alone.

Amgen’s Repatha is currently approved in 43 countries, including major markets in the US, Japan and Canada. While applications in other countries are pending, the drug is also available in all 28 member states in the EU.

Keywords: FDA, Medical Device, PCSK9 Inhibitor


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