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Repatha Approval History

  • FDA approved: Yes (First approved August 27th, 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) indicated for the treatment of patients with heterozygous familial hypercholesterolemia; homozygous familial hypercholesterolemia; and to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.

Development History and FDA Approval Process for Repatha

Dec  1, 2017Approval FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke
May 20, 2017Repatha (Evolocumab) Reduced Cardiovascular Events In Patients With Baseline LDL-C Levels Below Current Targets
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
Jan 31, 2014Amgen Announces Positive Top-Line Results From Phase 3 RUTHERFORD-2 Trial Of Evolocumab (AMG 145) In Patients With Heterozygous Familial Hypercholesterolemia
Nov 20, 2013Amgen: Evolocumab Cuts LDL 52%

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