Sarilumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Sarilumab
- kevzara
- Kevzara
- kevzara
- Kevzara (Sarilumab)
- kevzara sarilumab
- reg n88
- REG-N88
- regn 88
- REGN-88
- regn88
- REGN88
- sar 153191
- SAR-153191
- sar153191
- SAR153191
- SAR153191 (REGN88)
- sarilumab
- Sarilumab
- SARILUMAB
- sarilumab [INN]
- SARILUMAB [JAN]
- SARILUMAB [MI]
- SARILUMAB [PURPLE BOOK CDER]
- SARILUMAB [USAN]
- Sarilumab [WHO-DD]
- sarilumab inn
- sarilumab jan
And 6 more, listed on the interactive page.
- ATC classification codes
- L04AC14
Sources for recorded values
- CAS registry numbers
- 1189541-98-7
- ChEMBL ID
- CHEMBL2108730
- RxNorm IDs (RxCUI)
- 1923319
- FDA ingredient codes (UNII)
- NU90V55F8I
- Applicant
- SANOFI SYNTHELABO
- Approval date
- 22 May 2017
- Application number
- BLA761037
- Status
- Authorised
- Status date
- 23 Jun 2017
- Authorisation date
- 23 Jun 2017
- Approved indications
- Rheumatoid arthritisKevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumaticaKevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.
- Product number
- EMEA/H/C/004254
- 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
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Rheumatoid
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- sarilumab
- Type
- Antibody
- Drug name stem
- -aril-; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Interleukin-6 receptor alpha subunit antagonist
- Action type
- Antagonist
- Target
- Interleukin-6 receptor subunit alpha
- Protein identifier
- P08887
- Action
- Binding
- Action type
- Binding
- Target
- Interleukin-6 receptor, α subunit
- Gene symbol
- IL6R
- Protein identifier
- P08887
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Interleukin-6 receptor alpha subunit antagonist
- Action type
- Antagonist
- Target
- Interleukin-6 receptor subunit alpha
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Influenza, Human
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007328
- Subject identifier
- D007251
- Condition
- Polymyalgia Rheumatica
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008518
- Subject identifier
- D011111
- Condition
- Giant Cell Arteritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001209
- Subject identifier
- D013700
- Condition
- Uveitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001231
- Subject identifier
- D014605
- Condition
- Scleroderma, Localized
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001361
- Subject identifier
- D012594
- Condition
- Fallopian Tube Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0002158
- Subject identifier
- D005185
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition
- Lung Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0008903
- Subject identifier
- D008175
- Condition
- Mastocytosis, Systemic
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0016586
- Subject identifier
- D034721
- Condition
- Sarcoidosis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019338
- Subject identifier
- D012507
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000694
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008518
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001209
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001361
- Condition identifier
- HP_0011123
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002406
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005046
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005249
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005306
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005480
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005494
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0006502
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0008538
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008903
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0011429
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0016586
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019338
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019434
- Highest recorded phase
- 2
And 4 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 568
- Reporting signal score
- 1,691.94
- Event
- abdominal pain upper
- Reports
- 73
- Reporting signal score
- 50.9207
- Event
- adjustment disorder with depressed mood
- Reports
- 15
- Reporting signal score
- 58.9747
- Event
- alopecia
- Reports
- 580
- Reporting signal score
- 1,733.46
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 553
- Reporting signal score
- 3,324.6
- Event
- arthralgia
- Reports
- 302
- Reporting signal score
- 377.983
- Event
- arthritis
- Reports
- 62
- Reporting signal score
- 83.1341
- Event
- arthropathy
- Reports
- 510
- Reporting signal score
- 1,820.07
- Event
- blister
- Reports
- 173
- Reporting signal score
- 439.917
- Event
- blood cholesterol increased
- Reports
- 104
- Reporting signal score
- 241.694
- Event
- bone erosion
- Reports
- 18
- Reporting signal score
- 51.1935
- Event
- breast cancer
- Reports
- 31
- Reporting signal score
- 33.9543
- Event
- breast cancer stage iii
- Reports
- 12
- Reporting signal score
- 45.2435
- Event
- bursitis
- Reports
- 15
- Reporting signal score
- 24.6028
- Event
- c-reactive protein abnormal
- Reports
- 25
- Reporting signal score
- 64.1067
- Event
- c-reactive protein increased
- Reports
- 32
- Reporting signal score
- 30.8275
- Event
- condition aggravated
- Reports
- 494
- Reporting signal score
- 966.633
- Event
- contusion
- Reports
- 50
- Reporting signal score
- 47.3436
- Event
- deep vein thrombosis postoperative
- Reports
- 7
- Reporting signal score
- 28.5426
- Event
- disability
- Reports
- 13
- Reporting signal score
- 23.5804
- Event
- discomfort
- Reports
- 497
- Reporting signal score
- 1,950.74
- Event
- dislocation of vertebra
- Reports
- 15
- Reporting signal score
- 59.7222
- Event
- drug hypersensitivity
- Reports
- 79
- Reporting signal score
- 24.3783
- Event
- drug intolerance
- Reports
- 599
- Reporting signal score
- 1,789.33
- Event
- drug tolerance decreased
- Reports
- 28
- Reporting signal score
- 104.415
And 86 more, listed on the interactive page.
- NCT01011959
- NCT01026519
- NCT01055899
- NCT01061736
- NCT01146652
- NCT01217814
- NCT01328522
- NCT01709578
- NCT01764997
- NCT01768572
- NCT01850680
- NCT02017639
- NCT02057250
- NCT02097524
- NCT02121210
- NCT02293902
- NCT02332590
- NCT02373202
- NCT02404558
- NCT03414502
- NCT03449758
- NCT03535402
- NCT04134728
- NCT04842981
- NCT06159452
And 24 more, listed on the interactive page.
- Dose
- 200 mg
- Route
- Subcutaneous
- How often
- Once every 2 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLVESGGGLVQPGRSLRLSCAASRFTFDDYAMHWVRQAPGKGLEWVSGISWNSGRIGYADSVKGRFTISRDNAENSLFLQMNGLRAEDTALYYCAKGRDSFDIWGQGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- DIQMTQSPSSVSASVGDRVTITCRASQGISSWLAWYQQKPGKAPKLLIYGASSLESGVPSRFSGSGSGTDFTLTISSLQPEDFASYYCQQANSFPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0024-5908
- 0024-5910
- 0024-5920
- 0024-5922
Related records
Trials (61)
- A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
- A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
- A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
- A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
- A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
- A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
- A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
- A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
- A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
- An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
- An Observational Study on Sarilumab-exposed Pregnancies
- An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
- Anti-il6 Treatment of Serious COVID-19 Disease With Threatening Respiratory Failure
- Clinical Trial of Sarilumab in Adults With COVID-19
- Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI
- Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
- Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
- Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
- Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)
- Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Approved for (2)
In development for (16)
- Ankylosing spondylitis Phase 2
- COVID-19 Phase 3
- Fallopian tube cancer Phase 1
- Influenza Phase 3
- Juvenile idiopathic arthritis Phase 2
- Localized scleroderma Phase 1
- Lung cancer Phase 1
- Melanoma Phase 2
- Pneumonia Phase 3
- Polymyalgia rheumatica Phase 3
- Prostate cancer Phase 1
- Sarcoidosis Phase 2
- Severe acute respiratory syndrome Phase 3
- Systemic mastocytosis Phase 2
- Temporal arteritis Phase 3
- Uveitis Phase 2
Targets (1)
- IL6R Interleukin-6 receptor alpha subunit antagonist