Repatha FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 27, 2021.
FDA Approved: Yes (First approved August 27, 2015)
Brand name: Repatha
Generic name: evolocumab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: High Cholesterol; Prevention of Heart Attack and Stroke
Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) used for the treatment of familial hypercholesterolemia (heterozygous and homozygous), and to reduce the risk of adverse cardiovascular events in adults with established cardiovascular disease (CVD).
- Repatha is indicated:
- in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization
- as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C
- as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C
- as an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C.
- Repatha is administered via subcutaneous injection every 2 weeks, or once a month.
- Repatha may cause serious hypersensitivity reactions. Common side effects in patients with primary hyperlipidemia include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Common side effects in patients with established CVD include diabetes mellitus, nasopharyngitis and upper respiratory tract infection.
Development timeline for Repatha
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