Evolocumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Evolocumab
- repatha
- Repatha
- repatha sureclick
- Repatha sureclick
- amg 145
- AMG-145
- evolocumab
- Evolocumab
- EVOLOCUMAB (GENETICAL RECOMBINATION)
- evolocumab [INN]
- EVOLOCUMAB [JAN]
- EVOLOCUMAB [MI]
- EVOLOCUMAB [PURPLE BOOK CDER]
- EVOLOCUMAB [USAN]
- Evolocumab [WHO-DD]
- evolocumab genetical recombination
- evolocumab inn
- evolocumab jan
- evolocumab mi
- evolocumab purple book cder
- evolocumab usan
- evolocumab who dd
- Evolocumab(420 mg injections)
- immunoglobulin g2 lambda anti homo sapiens pcsk9 proprotein convertase subtilisin kexin type 9 homo sapiens monoclonal antibody
- IMMUNOGLOBULIN G2-LAMBDA, ANTI-(HOMO SAPIENS PCSK9 (PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9)), HOMO SAPIENS MONOCLONAL ANTIBODY
- Repatha
- Repatha®
- ATC classification codes
- C10AX13
Sources for recorded values
- CAS registry numbers
- 1256937-27-5
- ChEMBL ID
- CHEMBL2364655
- RxNorm IDs (RxCUI)
- 1665684
- FDA ingredient codes (UNII)
- LKC0U3A8NJ
- Applicant
- AMGEN INC
- Approval date
- 27 Aug 2015
- Application number
- BLA125522
- Status
- Authorised
- Status date
- 17 Jul 2015
- Authorisation date
- 17 Jul 2015
- Approved indications
- 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.
- Product number
- EMEA/H/C/003766
- Authorisation holder
- Amgen Europe B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Dyslipidemias
- Hypercholesterolemia
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 24 Sept 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- evolocumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- proprotein convertase subtilisin/kexin type 9
- Gene symbol
- PCSK9
- Protein identifier
- Q8NBP7
- Median affinity
- 9.72
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Subtilisin/kexin type 9 inhibitor
- Action type
- Inhibitor
- Target
- Proprotein convertase subtilisin/kexin type 9
- Protein identifier
- Q8NBP7
Open Targets mechanisms
- Mechanism
- Subtilisin/kexin type 9 inhibitor
- Action type
- Inhibitor
- Target
- Proprotein convertase subtilisin/kexin type 9
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Glioblastoma
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Stroke
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Coronary Artery Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001645
- Subject identifier
- D003324
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Aortic Aneurysm, Abdominal
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0004214
- Subject identifier
- D017544
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004911
- Subject identifier
- D006938
- Condition
- Acute Coronary Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005672
- Subject identifier
- D054058
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005708
- Subject identifier
- D002292
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Dyslipidemias
- Highest recorded phase
- 4
- Condition identifier
- HP:0003119
- Subject identifier
- D050171
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 4
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Sepsis
- Highest recorded phase
- 2
- Condition identifier
- HP:0100806
- Subject identifier
- D018805
- Condition
- Lung Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008903
- Subject identifier
- D008175
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018328
- Subject identifier
- D006938
- Condition
- Hyperlipidemias
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0021187
- Subject identifier
- D006949
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition
- Lipid Metabolism Disorders
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:309005
- Subject identifier
- D052439
- Condition
- Hyperlipidemia, Familial Combined
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:79211
- Subject identifier
- D006950
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0001645
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004214
- Condition identifier
- EFO_0004265
- Condition identifier
- EFO_0004911
- Condition identifier
- EFO_0005672
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008585
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008585
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008586
- Highest recorded phase
- 2
- Condition identifier
- EFO_0010673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0020921
- Condition identifier
- EFO_0020925
- Condition identifier
- HP_0001297
- Highest recorded phase
- 3
- Condition identifier
- HP_0003124
- Condition identifier
- HP_0003124
- Highest recorded phase
- 4
- Condition identifier
- HP_0100806
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002525
- Condition identifier
- MONDO_0002525
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004781
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004995
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005010
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005068
- Highest recorded phase
- 4
And 22 more, listed on the interactive page.
- Event
- back pain
- Reports
- 2,952
- Reporting signal score
- 2,701.64
- Event
- blood cholesterol decreased
- Reports
- 217
- Reporting signal score
- 602.75
- Event
- condition aggravated
- Reports
- 57
- Reporting signal score
- 574.208
- Event
- device defective
- Reports
- 272
- Reporting signal score
- 562.024
- Event
- device use error
- Reports
- 739
- Reporting signal score
- 1,067.51
- Event
- drug interaction
- Reports
- 19
- Reporting signal score
- 568.668
- Event
- influenza like illness
- Reports
- 1,900
- Reporting signal score
- 2,482.33
- Event
- injection site bruising
- Reports
- 2,370
- Reporting signal score
- 3,973.88
- Event
- injection site haemorrhage
- Reports
- 1,588
- Reporting signal score
- 2,660.58
- Event
- injection site mass
- Reports
- 653
- Reporting signal score
- 808.581
- Event
- injection site pain
- Reports
- 4,676
- Reporting signal score
- 5,444.37
- Event
- injection site swelling
- Reports
- 1,019
- Reporting signal score
- 742.513
- Event
- injury associated with device
- Reports
- 464
- Reporting signal score
- 825.308
- Event
- low density lipoprotein decreased
- Reports
- 359
- Reporting signal score
- 1,122.12
- Event
- low density lipoprotein increased
- Reports
- 524
- Reporting signal score
- 1,010.61
- Event
- muscle spasms
- Reports
- 1,612
- Reporting signal score
- 1,009.51
- Event
- myalgia
- Reports
- 2,971
- Reporting signal score
- 2,964.32
- Event
- nasopharyngitis
- Reports
- 1,284
- Reporting signal score
- 632.668
- Event
- pain in extremity
- Reports
- 1,912
- Reporting signal score
- 737.735
- Event
- rhinorrhoea
- Reports
- 2,177
- Reporting signal score
- 4,006.21
- Event
- wrong technique in device usage process
- Reports
- 284
- Reporting signal score
- 534.321
- Event
- wrong technique in product usage process
- Reports
- 7,200
- Reporting signal score
- 14,713.8
- NCT01133522
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- NCT01516879
- NCT01652703
- NCT01813422
- NCT01849497
- NCT02304484
- NCT02585895
And 23 more, listed on the interactive page.
- Dose
- 140 mg or 420 mg
- Route
- Subcutaneous
- How often
- Every 2 weeks or once monthly
Conditions of use
- Rotate injection sites after each administration
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVQSGAEVKKPGASVKVSCKASGYTLTSYGISWVRQAPGQGLEWMGWVSFYNGNTNYAQKLQGRGTMTTDPSTSTAYMELRSLRSDDTAVYYCARGYGMDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- ESALTQPASVSGSPGQSITISCTGTSSDVGGYNSVSWYQQHPGKAPKLMIYEVSNRPSGVSNRFSGSKSGNTASLTISGLQAEDEADYYCNSYTSTSMVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- 72511-143
- 72511-393
- 72511-501
- 72511-750
- 72511-760
Related records
Trials (181)
- A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis
- A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis
- A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
- A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
- A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
- A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
- A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
- A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy
- A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
- A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
- A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
- Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis
- Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
- Allergy Immunotherapy for the Reduction of Asthma
- An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
- Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine
- Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease
- Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
- Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease
- Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis
Approved for (6)
- Cardiovascular disorder
- Coronary artery disorder
- Familial hypercholesterolemia
- Homozygous familial hypercholesterolemia
- Myocardial infarction
- Stroke disorder
In development for (13)
- Abdominal aortic aneurysm Early phase 1
- Acute coronary syndrome Phase 3
- COVID-19 Phase 3
- Glioblastoma Early phase 1
- Heart failure Phase 2
- Hyperlipidemia Phase 3
- Hyperlipidemia, familial combined, LPL related Phase 3
- Inherited lipid metabolism disorder Phase 3
- Lung cancer Phase 2
- Non-small cell lung carcinoma Phase 1
- Renal cell adenocarcinoma Phase 2
- ST-elevation myocardial infarction Phase 2
- Type 2 diabetes mellitus Phase 3
Other linked conditions (2)
- Hypercholesterolemia, familial, 1
- Peripheral arterial disease
Targets (1)
- PCSK9 Subtilisin/kexin type 9 inhibitor