FDA approves single monthly injection of Amgen’s Repatha
pharmafile | July 12, 2016 | News story | Manufacturing and Production, Sales and Marketing | Amgen, FDA, Repatha, pushtronex
Amgen (NASDAQ: AMGN) has announced that the US Food and Drug Administration (FDA) has approved a new, monthly single-dose administration option for its cholesterol-lowering drug, Repatha (evolocumab).
The Repatha Pushtronex sustem is a hands-free device designed to provide 420mg of Repatha in a single dose. The cholesterol-lowering drug is a human monoclonal antibody that blocks proprotein convertase subtilisin/kexin type-9 (PCSK9), which inhibits the body’s natural system for eliminating “bad” cholesterol from the blood.
The drug was approved in the EU and the US last summer, representing a big win for Amgen. It 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, who require additional lowering of low-density lipoprotein cholesterol, or “bad” cholesterol. The pricing of Repatha remained an issue, however, with NICE initially rejecting and then recommending the drug.
Sean E. Harper, executive VP of R&D at Amgen, says: “The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients. Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration.”
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 price of Repatha is $14,100 annually. The Pushtronex system will be available to patients in the US in early August.
Sean Murray
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