The US Food and Drug Administration (FDA) recently cleared Amgen's Repatha (evolocumab) for the prevention of heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease. Repatha is the first PCSK9 inhibitor to be authorized for preventing such cardiovascular events.
Indications: Repatha is a PCSK9 inhibitor antibody indicated:
- to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease;
- as an adjunct to diet, alone or in combination with other lipid-lowering therapies (eg, statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C); and
- as an adjunct to diet and other LDL lowering therapies (eg, statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
Dosage/administration: Repatha is administered subcutaneously.
- For adults with established cardiovascular disease or primary hyperlipidemia (including heterozygous familial hypercholesterolemia): 140 mg every 2 weeks or 420 mg once monthly in abdomen, thigh, or upper arm.
- HoFH: 420 mg once monthly. The 420 mg dose can be administered over 9 minutes by using the single-use on-body infusor with prefilled cartridge, or by giving 3 injections consecutively within 30 minutes using the ingle-use prefilled autoinjector or single-use prefilled syringe.
Adverse reactions: Common adverse reactions in clinical trials in primary hyperlipidemia (>5% of patients treated with Repatha and occurring more frequently than placebo): nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
FDA approves Amgen's Repatha (evolocumab) to prevent heart attack and stroke. [news release]. Thousand Oaks, CA: Amgen. December 1, 2017. http://www.amgen.com/media/news-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke/. Accessed December 12, 2017.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10