Amgen Selects West’s Drug Delivery Technology
Amgen has selected West Pharmaceutical Services' drug delivery technology known as SmartDose, which allows patients to self-administer medication in accordance with prescribed treatment. Amgen combined West's technology with its own Pushtronex system to create an on-body infuser with a prefilled cartridge that delivers a monthly single dose of Repatha (evolocumab), Amgen's anti-cholesterol drug, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). The US Food and Drug Administration approved the new monthly single-dose Repatha Pushtronex system in July 2016, and it will be available to patients in the United States in early August.
West's SmartDose technology platform adheres to the patient's body, usually on the abdomen, to give patients a hands-free means to self-administer medication. The SmartDose technology platform is an integrated solution of delivery and containment that features a silicone-free Daikyo Crystal Zenith cartridge and a Flurotec-coated piston containment system, both by Japanese manufacturer Daikyo Seiko, which produces injectable packaging components.
Amgen's Pushtronex system is a hands-free device designed to provide 420 milligrams of Repatha in a single dose. Repatha blocks PCSK9, a protein that inhibits the body's natural system for eliminating low-density lipoprotein cholesterol, or LDL-C, commonly known as bad cholesterol.
Repatha in the United States is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease and who require additional lowering of LDL-C. It is also indicated as an adjunct to diet and other LDL-lowering therapies for patients over the age of 13 with homozygous familial hypercholesterolemia.