Evolocumab
Approved · FDA / EMAAlso known as Repatha.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: EVOLOCUMAB (BLA125522)
Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Label change: EVOLOCUMAB (BLA125522)
Label change: EVOLOCUMAB (BLA125522)
Label change: EVOLOCUMAB (BLA125522)
Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease.
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
— 30 supporting evidence families · 1 well-powered no-effect result
Confidence is moderated by well-powered no-effect evidence, despite broad trial support.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as… Show full indicationShow less
Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes7
Journals, researchers & institutions
- Journal of clinical lipidology2
- Arteriosclerosis, thrombosis, and vascular biology1
- Circulation1
- The American journal of cardiology1
- The New England journal of medicine1
- Adiels M2
- Andersson L2
- Björnson E2
- Blom DJ2
- Borén J2
- Giugliano RP2
- Hakkarainen A2
- Kahri J2
- HUS Medical Imaging Center2
- Institute of Cardiovascular and Medical Sciences2
- Aalto University School of Science1
- Abdominal Center (S.S.1
- Brigham and Women's Hospital1
- Brigham and Women's Hospital and Harvard Medical School1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.