Repatha Approved for Treating High Cholesterol
August 27, 2015 – The U.S. Food and Drug Administration (FDA) approved Repatha (evolocumab) for the treatment of high cholesterol among patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein “bad” cholesterol (LDL-C). Repatha is manufactured by Amgen. Repatha is a propotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be used along with diet as maximally tolerated HMG Co-reductase inhibitor (statin) therapy.
Familial hypercholesterolemia causes high levels of LDL – C and ASCVD is caused from a build-up of plaque in the arteries that can lead to conditions such as heart attack, stroke and chest pain. Clinical trials showed that Repatha reduced LDL-C by an additional 60% in patients on statin therapy. The recommended dose for Repatha is administered via by subcutaneous (SC) injection as either 140mg every two weeks or 420mg once a month. Repatha will be available through open distribution and through a preferred network of specialty pharmacies determined by Amgen that will provide additional patient services.
It should be noted that, a third PCSK9 inhibitor manufactured by Pfizer called bococizumab is expected to be approved in 2017. This approval for bococizumab is anticipated after the indications for Repatha may be expanded by the FDA when cardiovascular outcome data are available.
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