Skip to main content

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

Sep 24, 2021Approval FDA Approves Repatha (evolocumab) In Pediatric Patients Age 10 And Older With Heterozygous Familial Hypercholesterolemia
Jan  7, 2019Amgen Makes All Repatha (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price
Oct 24, 2018Amgen Makes Repatha (evolocumab) Available in the U.S. at a 60 Percent Reduced List Price
Dec  1, 2017Approval FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke
Jul 11, 2016Approval FDA Approves Repatha (evolocumab) Pushtronex - First And Only Single Monthly Injection for a PCSK9 Inhibitor
Aug 27, 2015Approval FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol
Apr 29, 2015Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) for High Cholesterol
Mar 15, 2015Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab)
Mar 14, 2015New Detailed Data From Phase 3 Study Show Amgen's Repatha (Evolocumab) In Combination With Statins Reduced LDL-C By 67-76 Percent Compared To Placebo
Nov 10, 2014FDA Accepts Amgen's BLA For LDL Cholesterol-Lowering Medication Evolocumab
Aug 28, 2014Amgen Submits BLA For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.