Drugs / Evolocumab
Evolocumab
also known as
Repatha · AMG 145 · Evolocumab (Repatha) · Rapatha · Repatha sureclick · Repatha; AMG 145
Monoclonal antibody targets PCSK9 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | REPATHA | — | 2016-07-08 – 2021-09-24 | fda.gov ↗ |
| Approved | US (FDA) | REPATHA | — | 2015-08-27 | fda.gov ↗ |
| Approved | EU (EMA) | Repatha | — | 2015-07-17 | europa.eu ↗ |
Trials 109 · started per year
today
EU approved 2015
US approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06081153 | Dec 2026 → Jan 2029 expected | abdominal aortic aneurysm | University of Pennsylvania | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06140095 | Feb 2024 → Dec 2025 | — | Region Stockholm | Unknown | No outcome recorded |
| Phase 0 | NCT04937413 | Oct 2021 → Sep 2023 | glioblastoma | Duke University | Completed | No outcome recorded |
| Phase 0 | NCT04862260 | Oct 2021 → Jan 2025 overdue | metastatic malignant neoplasm, pancreatic ductal adenocarcinoma | CHU de Quebec-Universite Laval | Active not recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07545226 | Apr → Sep 2026 expected | — | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07422285 | Jan → Jul 2026 overdue | — | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04189484 | Jan 2020 → Apr 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT02275156 | Aug → Dec 2014 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01133522 | Jun 2010 → Sep 2011 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04101643 | Sep 2019 → Jan 2023 | hereditary spastic paraplegia 5A | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT06496243 | Dec 2024 → Nov 2026 expected | hyperlipidemia | NewAmsterdam Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT06284564 | Aug 2024 → Oct 2026 expected | renal cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05144529 | Mar 2022 → Sep 2024 | lung cancer | Eziafa Oduah, MD, PhD, MPH | Terminated | No outcome recorded |
| Phase 2 | NCT04338165 | Jan 2021 → Nov 2022 | atherosclerotic cardiovascular disease | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 2 | NCT04303377 | Nov 2019 → Jan 2020 | ST-elevation myocardial infarction | Fondazione IRCCS Policlinico San Matteo di Pavia | Withdrawn | No outcome recorded |
| Phase 2 | NCT04082442 | Sep 2019 → Oct 2024 | acute coronary syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03944577 | Jul 2019 → Mar 2023 | — | University of Nebraska | Completed | No outcome recorded |
| Phase 2 | NCT03869073 | Feb 2019 → Feb 2021 | infectious disease with sepsis | University of British Columbia | Unknown | No outcome recorded |
| Phase 2 | NCT03791593 | Dec 2018 → Jun 2021 | symptomatic heart failure | Germans Trias i Pujol Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT03515304 | May 2018 → Oct 2024 | acute coronary syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03500302 | May 2018 → Nov 2019 | HIV infectious disease, coronary artery disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT01652703 | Jul 2012 → May 2013 | hyperlipoproteinemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01439880 | Oct 2011 → Jun 2018 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01375751 | Aug 2011 → May 2012 | familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01375764 | Jul 2011 → May 2012 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01375777 | Jul 2011 → Mar 2012 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01380730 | Jul 2011 → Apr 2012 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07174375 | Sep 2025 → Dec 2027 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06696820 | Nov 2024 → Mar 2026 | ischemic stroke | Xiang Luo | Completed | No outcome recorded |
| Phase 2/3 | NCT01624142 | Jun 2012 → May 2018 | familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 2/3 | NCT01588496 | Apr 2012 → Jan 2014 | homozygous familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 332 trials | ||||||
| Phase 3 | NCT04968509 | Mar 2024 → Dec 2027 expected | aortic valve stenosis | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05741086 | Apr 2023 → Aug 2024 | cerebral artery stenosis | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT04941105 | Jun 2021 → May 2022 | COVID-19 | Collegium Medicum w Bydgoszczy | Completed | No outcome recorded |
| Phase 3 | NCT06081803 | Dec 2020 → Dec 2025 overdue | ST-elevation myocardial infarction | Sejong General Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03872401 | Jun 2019 → Jul 2025 | coronary artery disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03734211 | Jun 2019 → May 2023 | — | Lars Gullestad | Completed | No outcome recorded |
| Phase 3 | NCT03433755 | May 2019 → Apr 2020 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT03689946 | Mar 2019 → Jan 2023 | cardiovascular disorder, hyperlipidemia | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03570697 | Nov 2018 → Dec 2020 | coronary artery disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02833844 | May 2017 → Jul 2019 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03080935 | Mar 2017 → Mar 2022 | hyperlipidemia | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT02624869 | Sep 2016 → Jun 2021 | familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02867813 | Sep 2016 → Mar 2022 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02739984 | May 2016 → Aug 2017 | hyperlipidemia, combined, 2, type 2 diabetes mellitus | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02662569 | Apr 2016 → Dec 2017 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02729025 | Apr 2016 → Apr 2018 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02392559 | Mar 2016 → Nov 2019 | familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02634580 | Feb 2016 → Aug 2017 | hyperlipoproteinemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02585895 | Dec 2015 → Sep 2016 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02304484 | Nov 2014 → Mar 2018 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02207634 | Sep 2014 → Nov 2016 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02189837 | Jul 2014 → Feb 2015 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01984424 | Dec 2013 → Nov 2015 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01953328 | Oct 2013 → Jun 2014 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01854918 | Apr 2013 → May 2018 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01813422 | Apr 2013 → Jul 2016 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01764633 | Feb 2013 → Nov 2016 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01763918 | Feb → Nov 2013 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01763905 | Jan → Nov 2013 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01763827 | Jan → Oct 2013 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01763866 | Jan → Nov 2013 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01516879 | Jan 2012 → Oct 2013 | hyperlipoproteinemia | Amgen | Completed | No outcome recorded |
| Phase 434 trials | ||||||
| Phase 4 | NCT07612774 | May 2026 → Dec 2028 expected | coronary artery disorder | West China Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07295366 | Dec 2025 → May 2026 | stroke disorder | The Affiliated Hospital of Xuzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT07301372 | Oct 2025 → Apr 2026 | stroke disorder | The Affiliated Hospital of Xuzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT07084259 | Jul 2025 → Jun 2030 expected | coronary artery disorder | Hanyang University Seoul Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05976893 | Aug 2023 → Dec 2025 | atherosclerotic cardiovascular disease, cancer | Xiang Xie | Unknown | No outcome recorded |
| Phase 4 | NCT05613426 | Apr 2023 → Jul 2025 | ST-elevation myocardial infarction | Henan Institute of Cardiovascular Epidemiology | Terminated | No outcome recorded |
| Phase 4 | NCT05697185 | Feb 2023 → Feb 2024 | ischemic stroke | Second Affiliated Hospital of Guangxi Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05623995 | Dec 2022 → Dec 2024 | coronary restenosis | Lin Zhao | Unknown | No outcome recorded |
| Phase 4 | NCT05641753 | Dec 2022 → Jul 2027 expected | type 1 diabetes mellitus | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05661552 | Dec 2022 → Feb 2025 | hyperlipoproteinemia | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT05585151 | Nov 2022 → Apr 2024 | cerebral atherosclerosis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT05284747 | Oct 2022 → May 2027 expected | coronary artery disorder, myocardial infarction, stroke disorder | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05802108 | Jul 2022 → Jun 2024 | — | Zibo Central Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05152888 | Mar 2022 → Mar 2027 expected | coronary artery disorder | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04951856 | Sep 2021 → May 2026 overdue | ST-elevation myocardial infarction | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04710368 | May 2021 → Oct 2022 | coronary atherosclerosis | Annapoorna Kini | Completed | No outcome recorded |
| Phase 4 | NCT04573777 | Apr → Dec 2021 | ischemic stroke | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 4 | NCT04510844 | Mar → Oct 2021 | chronic kidney disease | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT04608474 | Feb 2021 → Jan 2024 | hyperlipidemia | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04100434 | Jan 2021 → Jun 2022 | acute coronary syndrome | Tianjin Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04659525 | Nov 2020 → Nov 2021 | end stage renal failure, hyperlipidemia | Policlinico Casilino ASL RMB | Unknown | No outcome recorded |
| Phase 4 | NCT04369664 | Aug 2020 → Sep 2023 | type 2 diabetes mellitus | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT04397653 | May → Nov 2020 | end stage renal failure, hyperlipoproteinemia | Policlinico Casilino ASL RMB | Unknown | No outcome recorded |
| Phase 4 | NCT04306471 | Feb 2020 → Feb 2021 | limb ischemia | Leonardo Clavijo | Unknown | No outcome recorded |
| Phase 4 | NCT03851263 | Aug 2019 → Aug 2021 | coronary atherosclerosis | ECRI bv | Withdrawn | No outcome recorded |
| Phase 4 | NCT03811223 | Aug 2019 → Jan 2021 | hyperlipoproteinemia type 3 | UMC Utrecht | Unknown | No outcome recorded |
| Phase 4 | NCT03900026 | May 2019 → Jan 2025 | atherosclerosis, vascular occlusion disorder | Unity Health Toronto | Completed | No outcome recorded |
| Phase 4 | NCT06231459 | Jan 2019 → Dec 2020 | familial hypercholesterolemia | Institute for Social Security and Services for State Workers | Completed | No outcome recorded |
| Phase 4 | NCT03753555 | Dec 2018 → Nov 2027 expected | cerebral atherosclerosis, ischemic stroke | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| Phase 4 | NCT03403374 | Aug 2018 → Nov 2019 | homozygous familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04306081 | Dec 2017 → Dec 2020 | peripheral arterial disease | Leonardo Clavijo | Unknown | No outcome recorded |
| Phase 4 | NCT03096288 | Oct 2017 → Nov 2020 | atherosclerotic cardiovascular disease | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02941016 | Oct 2016 → Oct 2020 | combined low LDL and fibrinogen | Rigshospitalet, Denmark | Withdrawn | No outcome recorded |
| Phase 4 | NCT02948777 | Oct 2016 → Jun 2018 | type 2 diabetes mellitus | Marja-Riitta Taskinen | Completed | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT07704918 | Dec 2026 → Dec 2027 expected | melanoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| — | NCT07388420 | Jan → Dec 2026 expected | acute pancreatitis | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT06791031 | Jan 2026 → Dec 2027 expected | coronary atherosclerosis | West China Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06730802 | Jan 2025 → Dec 2026 expected | coronary artery disorder, myocardial ischemia | Nanjing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06364124 | Jun 2023 → Jun 2024 | ST-elevation myocardial infarction | Beijing Luhe Hospital | Unknown | No outcome recorded |
| — | NCT05624658 | Sep 2022 → May 2024 | hyperlipidemia | Samara Regional Cardiology Dispensary | Unknown | No outcome recorded |
| — | NCT05043740 | Oct 2021 → Oct 2023 | acute coronary syndrome | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| — | NCT04730648 | Apr 2021 → Apr 2022 | cardiovascular disorder | Shenzhen People's Hospital | Unknown | No outcome recorded |
| — | NCT04141579 | Nov 2020 → Nov 2023 | coronary atherosclerosis | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT04613167 | Nov 2020 → Jun 2021 | acute coronary syndrome, coronary artery disorder, hyperlipoproteinemia | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| — | NCT04314167 | Jul 2020 → Mar 2024 | hyperlipidemia | University Hospital Tuebingen | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 27 trials
Press releases naming this drug 82 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Amgen | POSITIVE CHMP OPINION SUPPORTS BROADER USE OF AMGEN'S REPATHA® BEFORE A FIRST HEART ATTACK OR STROKE amgen.com ↗ |
| 2026-03-28 | Amgen | REPATHA® CUTS RISK OF FIRST MAJOR CARDIOVASCULAR EVENTS BY 31% IN HIGH-RISK PATIENTS WITHOUT KNOWN SIGNIFICANT ATHEROSCLEROSIS amgen.com ↗ |
| 2025-11-08 | Amgen | AMGEN'S REPATHA® CUTS RISK OF FIRST MAJOR ADVERSE CARDIOVASCULAR EVENTS BY 25% IN LANDMARK PHASE 3 VESALIUS-CV TRIAL amgen.com ↗ |
| 2025-10-31 | Amgen | AMGEN'S LANDMARK PHASE 3 REPATHA DATA TO BE PRESENTED AS LATE BREAKER AT THE AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2025 amgen.com ↗ |
| 2025-10-06 | Amgen | AMGEN MAKES REPATHA® AVAILABLE THROUGH AMGENNOW, A DIRECT-TO-PATIENT PROGRAM IN THE U.S. amgen.com ↗ |
| 2025-08-25 | Amgen | REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C amgen.com ↗ |
| 2023-03-01 | Amgen | AMGEN TO PRESENT NEW REPATHA® (EVOLOCUMAB) AND OLPASIRAN DATA AT ACC amgen.com ↗ |
| 2022-11-07 | Amgen | AMGEN PRESENTS NEW REPATHA® (EVOLOCUMAB) DATA AT AHA 2022 amgen.com ↗ |
| 2022-09-02 | Amgen | 2022年欧州心臓病学会学術集会でREPATHA® (EVOLOCUMAB) が8年以上の長期間LDL-C低下作用を示すとともに、忍容性も確認された結果が発表される amgen.co.jp ↗ |
| 2022-08-29 | Amgen | NEW AMGEN DATA AT ESC 2022 SHOW LONG-TERM LDL-C LOWERING WITH REPATHA® (EVOLOCUMAB) WAS WELL-TOLERATED FOR MORE THAN 8 YEARS amgen.com ↗ |
| 2022-08-22 | Amgen | AMGEN TO PRESENT NEW DATA AT ESC CONGRESS 2022 HIGHLIGHTING UP TO 8.5 YEARS OF REPATHA® (EVOLOCUMAB) SAFETY AND TOLERABILITY DATA IN HIGH-RISK ASCVD PATIENT POPULATIONS amgen.com ↗ |
| 2022-04-27 | Amgen | AMGEN ANNOUNCES RESULTS FROM TWO OPEN LABEL EXTENSION STUDIES OF REPATHA® (EVOLOCUMAB) amgen.com ↗ |
| 2021-09-25 | Amgen | FDA Approves Repatha® (evolocumab) In Pediatric Patients Age 10 And Older With Heterozygous Familial Hypercholesterolemia amgen.com ↗ |
| 2021-08-27 | Amgen | New Data At ESC Congress 2021 Shows Repatha® (evolocumab) Improves Features Of Plaque Stability In Patients With Acute Coronary Syndrome (ACS) amgen.com ↗ |
| 2021-05-11 | Amgen | Efficacy Of Repatha® (Evolocumab) Across High-Risk Patient Populations Reinforced At ACC.21 amgen.com ↗ |
| 2020-08-29 | Amgen | Amgen Announces Positive Data From Phase 3B Study Of Repatha® (Evolocumab) In Pediatric Patients With Heterozygous Familial Hypercholesterolemia At ESC Congress 2020 amgen.com ↗ |
| 2020-08-25 | Amgen | New Amgen Data To Be Presented At ESC Congress 2020 Highlighting Repatha® (evolocumab) Efficacy In High-Risk Patient Populations amgen.com ↗ |
| 2020-03-28 | Amgen | Amgen Announces Positive Results At ACC.20/WCC From Phase 3B Study Of Repatha® (Evolocumab) In People Living With HIV Who Have High LDL-Cholesterol amgen.com ↗ |
| 2019-11-16 | Amgen | Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack amgen.com ↗ |
| 2019-10-24 | Amgen | Amgen To Make Repatha® (evolocumab) Available Exclusively At Its Lower List Price Option In 2020 amgen.com ↗ |
| 2019-08-28 | Amgen | New Amgen Data To Be Presented At ESC Congress 2019 Highlight Additional Evidence For Repatha® (Evolocumab) Effectiveness In Cardiovascular Disease Across Multiple Patient Groups amgen.com ↗ |
| 2019-03-15 | Amgen | Amgen Announces New Four-Year Outcomes Study To Examine Long-Term Effects Of Repatha® (evolocumab) In High-Risk Cardiovascular Disease (CVD) Patients Without Prior Heart Attack Or Stroke amgen.com ↗ |
| 2019-03-06 | Amgen | New Data From Amgen To Be Presented At ACC.19 Continues To Build Evidence For Repatha® (evolocumab) Across Multiple Patient Populations amgen.com ↗ |
| 2019-02-25 | Amgen | Jury Upholds Amgen's Patents On Repatha® (evolocumab) amgen.com ↗ |
| 2019-01-24 | Amgen | Amgen Receives NMPA Approval For Repatha® (evolocumab) In China To Reduce The Risk Of Cardiovascular Events amgen.com ↗ |
| 2019-01-07 | Amgen | Amgen Makes All Repatha® (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price amgen.com ↗ |
| 2018-11-12 | Amgen | Amgen Presents Results Highlighting The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In The Longest Duration Study Of A PCSK9 Inhibitor To Date At AHA Scientific Sessions 2018 amgen.com ↗ |
| 2018-11-05 | Amgen | Amgen Announces Presentation Of Research Reinforcing The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In High-Risk Patients At AHA Scientific Sessions 2018 amgen.com ↗ |
| 2018-10-26 | Amgen | Amgen Announces New FOURIER Analysis Showing Benefit With Repatha® (Evolocumab) In High-Risk Patients With Established Cardiovascular Disease And Chronic Kidney Disease amgen.com ↗ |
| 2018-10-24 | Amgen | Amgen Makes Repatha® (Evolocumab) Available In The US At A 60 Percent Reduced List Price amgen.com ↗ |
| 2018-08-21 | Amgen | Amgen To Present Robust Data Exploring The Impact Of Treatment With Repatha® (evolocumab) Across Patient Subgroups And High-Risk Populations At ESC Congress 2018 amgen.com ↗ |
| 2018-06-23 | Amgen | New Data Show Amgen's Repatha® (evolocumab) Significantly Reduced LDL-C And Non-HDL-C In High-risk Patients With Type 2 Diabetes amgen.com ↗ |
| 2018-05-16 | Amgen | Amgen Receives European Commission Approval For Repatha® (Evolocumab) To Prevent Heart Attack And Stroke In Adults With Established Cardiovascular Disease amgen.com ↗ |
| 2018-03-23 | Amgen | Amgen Receives Positive CHMP Opinion Recognizing That Repatha® (evolocumab) Prevents Heart Attacks And Strokes amgen.com ↗ |
| 2018-02-26 | Amgen | Amgen To Present New Data From Repatha® (evolocumab) Clinical Trials At ACC.18 amgen.com ↗ |
| 2017-12-01 | Amgen | FDA Approves Amgen's Repatha® (evolocumab) To Prevent Heart Attack And Stroke amgen.com ↗ |
| 2017-11-13 | Amgen | New Analyses Presented At AHA 2017 Show Repatha® (evolocumab) Significantly Reduced Cardiovascular Events In Patients With Peripheral Artery Disease And In Patients With A History Of Heart Attacks amgen.com ↗ |
| 2017-11-06 | Amgen | Amgen Announces New Analyses Of High-Risk Patient Subgroups From Repatha® (evolocumab) Cardiovascular Outcomes Study At AHA Scientific Sessions 2017 amgen.com ↗ |
| 2017-09-15 | Amgen | New FOURIER Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With Diabetes amgen.com ↗ |
| 2017-08-29 | Amgen | New Virtual Histology Sub-Study Evaluates Impact Of Repatha® (Evolocumab) On Coronary Artery Plaque Composition amgen.com ↗ |
| 2017-08-29 | Amgen | New Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With History Of Stroke amgen.com ↗ |
| 2017-08-28 | Amgen | New Repatha® (evolocumab) Analysis Demonstrates Cardiovascular Outcomes Efficacy And Safety Of Achieving Very Low LDL-C Levels amgen.com ↗ |
| 2017-08-23 | Amgen | New Economic Analysis Based On Repatha® (Evolocumab) Outcomes Data Published In JAMA Cardiology amgen.com ↗ |
| 2017-08-21 | Amgen | Amgen To Present New Data From The Repatha® (Evolocumab) Cardiovascular Outcomes Study At ESC Congress 2017 amgen.com ↗ |
| 2017-08-16 | Amgen | Repatha® (Evolocumab) Phase 3 Cognitive Function Study Results Published In The New England Journal Of Medicine amgen.com ↗ |
| 2017-07-27 | Amgen | FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events amgen.com ↗ |
| 2017-06-05 | Amgen | Amgen Submits Regulatory Applications For Repatha® (evolocumab) Cardiovascular Outcomes Data In US And Europe amgen.com ↗ |
| 2017-05-20 | Amgen | Repatha® (Evolocumab) Reduced Cardiovascular Events In Patients With Baseline LDL-C Levels Below Current Targets amgen.com ↗ |
| 2017-05-02 | Amgen | Amgen And Harvard Pilgrim Agree To First Cardiovascular Outcomes-Based Refund Contract For Repatha® (Evolocumab) amgen.com ↗ |
| 2017-03-18 | Amgen | Lowering LDL Levels With Repatha® (Evolocumab) Did Not Adversely Affect Cognitive Function In Landmark Phase 3 Study amgen.com ↗ |
| 2017-03-17 | Amgen | Landmark Outcomes Study Shows That Repatha® (Evolocumab) Decreases LDL-C To Unprecedented Low Levels And Reduces Risk Of Cardiovascular Events With No New Safety Issues amgen.com ↗ |
| 2017-03-14 | Amgen | Repatha® (Evolocumab) Four-Year Open-Label Follow-Up Study Published In 'JAMA Cardiology' amgen.com ↗ |
| 2017-03-13 | Amgen | Repatha® (Evolocumab) Demonstrates Reduced Need For Apheresis In Patients With High LDL Cholesterol In Phase 3 Study amgen.com ↗ |
| 2017-03-06 | Amgen | Amgen Highlights Landmark Repatha® (Evolocumab) Cardiovascular Outcomes Study Amongst Data To Be Presented At ACC.17 amgen.com ↗ |
| 2017-02-21 | Amgen | Repatha® (Evolocumab) Receives European Commission Approval For New 420 mg Single-Dose Delivery Option amgen.com ↗ |
| 2017-02-02 | Amgen | Amgen Announces Repatha® (Evolocumab) Significantly Reduced The Risk Of Cardiovascular Events In FOURIER Outcomes Study amgen.com ↗ |
| 2017-01-06 | Amgen | Court Grants Permanent Injunction For Infringement Of Amgen's Repatha® Patents amgen.com ↗ |
| 2016-12-16 | Amgen | New Repatha® (evolocumab) Dose Delivery Option Receives Positive CHMP Opinion amgen.com ↗ |
| 2016-11-15 | Amgen | Repatha® (Evolocumab) Regresses Atherosclerosis In Patients With Coronary Artery Disease amgen.com ↗ |
| 2016-10-31 | Amgen | Amgen Highlights Repatha® (Evolocumab) GLAGOV Imaging Study Amongst Data To Be Presented At AHA Scientific Sessions 2016 amgen.com ↗ |
| 2016-09-20 | Amgen | Amgen Announces Positive Top-Line Results From Phase 3 GLAGOV Imaging Study Of Repatha® (Evolocumab) amgen.com ↗ |
| 2016-08-28 | Amgen | New Repatha® (evolocumab) Analyses Show Efficacy And Safety Across Risk Groups In Results Presented At ESC Congress 2016 amgen.com ↗ |
| 2016-08-22 | Amgen | New Data Add To Understanding Of Repatha® (Evolocumab) In Multiple Patient Populations amgen.com ↗ |
| 2016-04-03 | Amgen | Positive Efficacy And Tolerability Study Of Repatha® (evolocumab) In Statin-Intolerant Patients Published In Journal of the American Medical Association amgen.com ↗ |
| 2016-03-21 | Amgen | Amgen To Present Repatha® (Evolocumab) Data At ACC.16 amgen.com ↗ |
| 2016-03-16 | Amgen | Amgen Wins Patent Case On Repatha® (Evolocumab) amgen.com ↗ |
| 2016-02-04 | Amgen | Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol amgen.com ↗ |
| 2016-01-22 | Amgen | Amgen's Repatha® (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol amgen.com ↗ |
| 2015-11-23 | Amgen | Amgen Announces Repatha® Preferred Position On CVS Health Commercial Formularies amgen.com ↗ |
| 2015-10-06 | Amgen | Amgen Announces Repatha™ Co-Preferred Position on Express Scripts National Formulary amgen.com ↗ |
| 2015-09-11 | Amgen | Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha™ (Evolocumab) amgen.com ↗ |
| 2015-08-27 | Amgen | FDA Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab) amgen.com ↗ |
| 2015-08-25 | Amgen | Amgen To Present New Long-Term Repatha™ (Evolocumab) Data Analysis At ESC Congress 2015 amgen.com ↗ |
| 2015-07-21 | Amgen | European Commission Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol amgen.com ↗ |
| 2015-06-10 | Amgen | Amgen To Discuss Details Of Repatha™ (Evolocumab) Biologics License Application For The Treatment Of High Cholesterol amgen.com ↗ |
| 2015-06-05 | Amgen | Amgen Completes Enrollment In Large Cardiovascular Outcomes Trial Of Repatha™ (Evolocumab) In Patients With High Cholesterol And Clinically Evident Cardiovascular Disease amgen.com ↗ |
| 2015-05-22 | Amgen | Amgen Receives Positive CHMP Opinion For Use Of Repatha™ (Evolocumab) For The Treatment Of High Cholesterol amgen.com ↗ |
| 2015-04-29 | Amgen | Amgen Announces FDA Advisory Committee Meeting To Review Repatha™ (Evolocumab) As A Treatment For High Cholesterol amgen.com ↗ |
| 2015-03-20 | Amgen | Amgen Submits Application For Investigational LDL Cholesterol-Lowering Medication Repatha™ (evolocumab) In Japan amgen.com ↗ |
| 2015-03-15 | Amgen | Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha™ (evolocumab) In The New England Journal of Medicine amgen.com ↗ |
| 2015-03-14 | Amgen | 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 In Japanese Patients With High Cardiovascular Risk And High Cholesterol amgen.com ↗ |
| 2014-11-18 | Amgen | Amgen Presents Long-Term Data Showing Efficacy And Safety Of Investigational Cholesterol-Lowering Medication Evolocumab Across Lipid And LDL-C Levels amgen.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 138 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Evolocumab | “Patients randomized to the "PCSK9i early" intensified therapy group will receive initial treatment with a PCSK9 inhibitor-either evolocumab 140 mg or alirocumab 75 mg, both...” NCT06791031 ↗134“Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after...” NCT07174375 ↗ “This study sought to evaluate the ability of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab to reduce the risk of complex coronary...” PMID 33197560 ↗ Nov 2020 “Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label...” NCT05624658 ↗ “Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%.” PMID 28304224 ↗ Mar 2017 “A combination of a lipophilic statin (Atorvastatin, Lipitor), a NPC1L1 inhibitor (Ezetimibe, Ezetrol) and a PCSK9 inhibitor (Evolocumab, Repatha) with chemotherapy in pancreatic cancer” NCT04862260 ↗ “Patients in experimental group are treated with PCSK9 inhibitors (140mg with Evolocumab or 75mg with Alirocumab or 150mg with Tafolecimab subcutaneously every two weeks)” NCT04968509 ↗ “Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months” NCT05043740 ↗ “In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab).” NCT04656028 ↗ “The patients with ACS received one dose of subcutaneous evolocumab (140 mg) on top of 10 mg/day rosuvastatin during hospitalization.” PMID 36017088 ↗ Aug 2022 “PCSK9 inhibitors (Evolocumab 140 mg or Alirocumab 75 mg or Alirocumab 150 mg) plus Ezetimibe 10 mg plus Bempedoic acid (Treatment A)” NCT06381947 ↗ “Patients will receive the PCSK9-inhibitor Evolocumab as part of routine clinical management within the indication of this drug.” NCT04314167 ↗ “Evolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy..” NCT05623995 ↗ “monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously)” NCT05537948 ↗ “Administer 420 mg (three vials) of evolocumab subcutaneously within 24 hours after thrombolysis.” NCT07301372 ↗ “For patients with concomitant dyslipidemia, statins and evolocumab may be added” NCT07286110 ↗ “The evolocumab group will receive 420 mg before PCI via subcutaneous injection.” NCT06081803 ↗ “A single subcutaneous injection of 420 mg Evolocumab upon admission” NCT06696820 ↗ “Evolocumab 140mg subcutaneously injected, twice each month” NCT03753555 ↗ “Evolocumab (Repatha)” NCT07084259 ↗ “Evolocumab” NCT04369664 ↗ |
| Known as | AMG 145 | “Evolocumab (also known as Repatha, formerly referred to as AMG 145) is a human monoclonal immunoglobulin G2 (IgG2) that specifically binds to proprotein convertase...” NCT04141579 ↗2“A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia” NCT01624142 ↗ “evolocumab (AMG 145)” NCT02867813 ↗ |
| Known as | Evolocumab (Repatha) | “Evolocumab (Repatha)” NCT07084259 ↗ |
| Known as | Rapatha | “Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel...” NCT03331666 ↗ |
| Known as | Repatha | “REPATHA (evolocumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); it will be...” NCT03900026 ↗14“A combination of a lipophilic statin (Atorvastatin, Lipitor), a NPC1L1 inhibitor (Ezetimibe, Ezetrol) and a PCSK9 inhibitor (Evolocumab, Repatha) with chemotherapy in pancreatic cancer” NCT04862260 ↗ “Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months” NCT05043740 ↗ “Evolocumab (Repatha®) will be administered subcutaneously once monthly in the abdomen, thigh, or upper arm for the duration of the treatment period (one year).” NCT03734211 ↗ “The purpose of this study is to evaluate the effect of evolocumab (Repatha®)-a Food and Drug Administration (FDA)-approved biological drug” NCT04510844 ↗ “Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.” NCT03944577 ↗ “Subjects will receive evolocumab (Repatha) 140 mg subcutaneously every 2 weeks for 26 weeks.” NCT04710368 ↗ “Evolocumab (trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc” NCT04608474 ↗ “Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]” NCT05613426 ↗ “evolocumab (Repatha) 420mg injection once monthly” NCT03193047 ↗ “Drug: Evolocumab 140 MG/ML [Repatha]” NCT04338165 ↗ “Evolocumab Auto-Injector [Repatha]” NCT03811223 ↗ “Evolocumab 140 MG/ML [Repatha]” NCT07388420 ↗ “Evolocumab 140 mg/mL, Repatha®” NCT04992065 ↗ |
| Known as | Repatha sureclick | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364655 ↗ |
| Known as | Repatha; AMG 145 | “Repatha; AMG 145” NCT03433755 ↗ |
| Action | Inhibit | “a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9)” PMID 25773607 ↗ Mar 2015 |
| Modality | Monoclonal antibody | “Monoclonal Antibody Against PCSK9” NCT01375777 ↗ |
| Route | Subcutaneous | “Administered by subcutaneous injection” NCT01133522 ↗ |
| Target | PCSK9 | “Anti-PCSK9 Antibody” NCT01375764 ↗ |