FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor

THOUSAND OAKS, Calif., Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha^® (evolocumab) Pushtronex^™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.¹ 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 "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option. 

"The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients," said Sean E. Harper, M.D., 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."

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.

The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually, whether it is delivered monthly via Pushtronex system or every two weeks via 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 insurance status and eligibility for patient assistance. The Pushtronex system will be available to patients in the U.S. in early August.

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. FH 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 FH, yet less than one percent are diagnosed.

Source:  Amgen