Repatha Approval History
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) 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
|Jan 7, 2019||Amgen Makes All Repatha (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price|
|Oct 24, 2018||Amgen Makes Repatha (evolocumab) Available in the U.S. at a 60 Percent Reduced List Price|
|Dec 1, 2017|| FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke|
|May 20, 2017||Repatha (Evolocumab) Reduced Cardiovascular Events In Patients With Baseline LDL-C Levels Below Current Targets|
|Jul 11, 2016|| FDA Approves Repatha (evolocumab) Pushtronex - First And Only Single Monthly Injection for a PCSK9 Inhibitor|
|Aug 27, 2015|| FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol|
|Apr 29, 2015||Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) for High Cholesterol|
|Mar 15, 2015||Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab)|
|Mar 14, 2015||New 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, 2014||FDA Accepts Amgen's BLA For LDL Cholesterol-Lowering Medication Evolocumab|
|Aug 28, 2014||Amgen Submits BLA For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab|
|Jan 31, 2014||Amgen Announces Positive Top-Line Results From Phase 3 RUTHERFORD-2 Trial Of Evolocumab (AMG 145) In Patients With Heterozygous Familial Hypercholesterolemia|
|Nov 20, 2013||Amgen: Evolocumab Cuts LDL 52%|
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