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Repatha Approval History

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

The recommended dose of Repatha for adults with HeFH or atherosclerotic CVD is 140 mg every two weeks or 420 mg once a month. For adults with HoFH, the recommended dose is 420 mg once a month. Repatha is available as a single-use prefilled syringe, a single-use prefilled SureClick® autoinjector, or a single-use PushtronexTM system (on-body infusor with prefilled cartridge).

Common side effects with Repatha use include nasopharyngitis (common cold), upper respiratory tract infections, influenza, back pain, and injection site reactions like redness, pain or bruising. Allergic reactions, such as rash and hives, have been reported. Patients should stop using Repatha and seek emergency medical care if they experience symptoms of a serious allergic reaction, such as swelling of the lips, tongue or throat.

Development History and FDA Approval Process for Repatha

DateArticle
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%

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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