FDA Will Review New Dosing Option for Repatha
Amgen announced the submission of an application to the Food and Drug Administration (FDA) seeking approval of a single-injection option for the monthly administration of the 420mg dose of Repatha (evolocumab) Injection.
Repatha, a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), is available as a single-use 140mg/mL prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose of 140mg every two weeks or 420mg once a month. Currently, multiple injections are required to achieve the 420mg dose.
The FDA approved Repatha on August 27, 2015 as an adjunct to diet and maximally tolerated statins in patients 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) who require additional lowering of LDL-C.
For more information call (800) 772–6436 or visit Amgen.com.