Alirocumab
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
- Alirocumab
- praluent
- Praluent
- alirocumab
- Alirocumab
- Alirocumab (Lyophilized formulation)
- alirocumab [INN]
- ALIROCUMAB [JAN]
- ALIROCUMAB [MI]
- ALIROCUMAB [PURPLE BOOK CDER]
- ALIROCUMAB [USAN]
- Alirocumab [WHO-DD]
- Alirocumab 150 mg
- alirocumab inn
- alirocumab jan
- alirocumab mi
- alirocumab purple book cder
- alirocumab SAR236553 (REGN727)
- Alirocumab SAR236553 (REGN727)
- ALIROCUMAB SAR236553 (REGN727)
- alirocumab usan
- alirocumab who dd
- immunoglobulin g1 anti human neural apoptosis regulated proteinase 1 human regn727 heavy chain disulfide with human regn727 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN NEURAL APOPTOSIS-REGULATED PROTEINASE 1) (HUMAN REGN727 HEAVY CHAIN), DISULFIDE WITH HUMAN REGN727 .KAPPA.-CHAIN, DIMER
- Praluent
- Praluent (Alirocumab)
- regn 727
- REGN-727
And 7 more, listed on the interactive page.
- ATC classification codes
- C10AX14
Sources for recorded values
- CAS registry numbers
- 1245916-14-6
- ChEMBL ID
- CHEMBL2109540
- RxNorm IDs (RxCUI)
- 1659152
- FDA ingredient codes (UNII)
- PP0SHH6V16
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 24 Jul 2015
- Application number
- BLA125559
- Status
- Authorised
- Status date
- 23 Sept 2015
- Authorisation date
- 23 Sept 2015
- Approved indications
- Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular 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/003882
- Authorisation holder
- Sanofi Winthrop Industrie
- 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
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 1 Apr 2028
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- alirocumab
- 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
- 9.42
- 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
- Diabetes Mellitus
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Coronary Artery Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001645
- Subject identifier
- D003324
- Condition
- Atherosclerosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004911
- Subject identifier
- D006938
- Condition
- Dyslipidemias
- Highest recorded phase
- 4
- Condition identifier
- HP:0003119
- Subject identifier
- D050171
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Sepsis
- Highest recorded phase
- 1
- Condition identifier
- HP:0100806
- Subject identifier
- D018805
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018328
- Subject identifier
- D006938
- Condition
- Lipid Metabolism Disorders
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:309005
- Subject identifier
- D052439
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000400
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001645
- Condition identifier
- EFO_0003914
- Condition identifier
- EFO_0004255
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004264
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004911
- Condition identifier
- EFO_0006834
- Highest recorded phase
- 2
- Condition identifier
- EFO_0020921
- Condition identifier
- HP_0001297
- Condition identifier
- HP_0003119
- Condition identifier
- HP_0003119
- Highest recorded phase
- 4
- Condition identifier
- HP_0003124
- Condition identifier
- HP_0003124
- Highest recorded phase
- 4
- Condition identifier
- HP_0100806
- Highest recorded phase
- 1
- Condition identifier
- HP_0100806
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002525
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004781
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004995
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005010
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005068
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005264
And 7 more, listed on the interactive page.
- Event
- arthralgia
- Reports
- 223
- Reporting signal score
- 65.1808
- Event
- blood cholesterol increased
- Reports
- 59
- Reporting signal score
- 57.101
- Event
- blood triglycerides increased
- Reports
- 49
- Reporting signal score
- 61.9818
- Event
- device defective
- Reports
- 26
- Reporting signal score
- 53.1357
- Event
- device operational issue
- Reports
- 54
- Reporting signal score
- 222.703
- Event
- device use issue
- Reports
- 83
- Reporting signal score
- 244.546
- Event
- influenza like illness
- Reports
- 199
- Reporting signal score
- 272.267
- Event
- injection site bruising
- Reports
- 155
- Reporting signal score
- 201.952
- Event
- injection site erythema
- Reports
- 155
- Reporting signal score
- 99.2014
- Event
- injection site haemorrhage
- Reports
- 85
- Reporting signal score
- 95.7794
- Event
- injection site pain
- Reports
- 222
- Reporting signal score
- 124.5
- Event
- injection site pruritus
- Reports
- 106
- Reporting signal score
- 89.123
- Event
- injection site rash
- Reports
- 92
- Reporting signal score
- 137.195
- Event
- injection site swelling
- Reports
- 98
- Reporting signal score
- 70.0564
- Event
- injury associated with device
- Reports
- 85
- Reporting signal score
- 202.181
- Event
- low density lipoprotein decreased
- Reports
- 38
- Reporting signal score
- 121.715
- Event
- low density lipoprotein increased
- Reports
- 182
- Reporting signal score
- 576.629
- Event
- muscle spasms
- Reports
- 211
- Reporting signal score
- 180.963
- Event
- myalgia
- Reports
- 403
- Reporting signal score
- 520.187
- Event
- pain in extremity
- Reports
- 196
- Reporting signal score
- 81.6425
- Event
- product administered at inappropriate site
- Reports
- 67
- Reporting signal score
- 212.754
- Event
- product dose omission issue
- Reports
- 141
- Reporting signal score
- 172.398
- Event
- rhinorrhoea
- Reports
- 88
- Reporting signal score
- 90.8889
- Event
- wrong technique in device usage process
- Reports
- 93
- Reporting signal score
- 281.881
- NCT01161082
- NCT01266876
- NCT01288443
- NCT01288469
- NCT01443650
- NCT01448239
- NCT01448304
- NCT01448317
- NCT01507831
- NCT01576484
- NCT01604824
- NCT01623115
- NCT01644175
- NCT01644188
- NCT01644474
- NCT01670734
- NCT01709513
- NCT01723735
- NCT01730040
- NCT01730053
- NCT01785329
- NCT01812707
- NCT01926782
- NCT01954394
- NCT01959971
And 23 more, listed on the interactive page.
- Dose
- 75 mg or 150 mg or 300 mg
- Route
- Subcutaneous
- How often
- Every 2 weeks or every 4 weeks
Conditions of use
- Rotate injection sites
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFNNYAMNWVRQAPGKGLDWVSTISGSGGTTNYADSVKGRFIISRDSSKHTLYLQMNSLRAEDTAVYYCAKDSNWGNFDLWGRGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- DIVMTQSPDSLAVSLGERATINCKSSQSVLYRSNNRNFLGWYQQKPGQPPNLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQYYTTPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0024-5901
- 0024-5902
- 61755-020
- 61755-021
Related records
Trials (98)
- A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
- A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects
- A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
- A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
- Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
- Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
- Alirocumab and Plaque Burden In Familial Hypercholesterolaemia
- Alirocumab and Reverse Cholesterol Transport
- Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque
- Alirocumab in Patients on a Stable Dialysis Regimen
- Alirocumab in Patients With Acute Myocardial Infarction
- Alirocumab in Patients with Sepsis
- An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
- Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
- Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers
- Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers
- Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
- Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab
Approved for (5)
- Atherosclerosis
- Cardiovascular disorder
- Coronary artery disorder
- Familial hypercholesterolemia
- Homozygous familial hypercholesterolemia
In development for (4)
- Diabetes mellitus Phase 3
- Inherited lipid metabolism disorder Phase 3
- Nephrotic syndrome Phase 2
- Vascular disorder Phase 2
Targets (1)
- PCSK9 Subtilisin/kexin type 9 inhibitor