FDA approves first and only single monthly injection for a PCSK9 inhibitor

Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option.

"The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients," said Sean E. Harper, executive vice president of R&D 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 US, 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 US Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually, whether it is delivered monthly via Pushtronex system or every 2 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 US in early August.