Repatha FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 26, 2025.
FDA Approved: Yes (First approved August 27, 2015)
Brand name: Repatha
Generic name: evolocumab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: High Cholesterol, High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, Cardiovascular Risk Reduction
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 major adverse cardiovascular events in at-risk adults.
- Repatha is indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
- as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
• adults with hypercholesterolemia.
• adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
• adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). - Repatha is administered via subcutaneous injection every 2 weeks, or once a month.
- Repatha may cause serious hypersensitivity reactions.
- Common (> 5% of patients treated with Repatha and more frequently than placebo) adverse reactions in adults with:
- primary hypercholesterolemia include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
- established cardiovascular disease include diabetes mellitus, nasopharyngitis and upper respiratory tract infection.
Development timeline for Repatha
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.