bimekizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
monoclonal antibodies (humanized origin); interleukin and interleukin receptors 5478 1418205-77-2

Description:

MoleculeDescription

Molfile

Synonyms:

  • bimekizumab
  • bimzelx
  • UCB4940
  • bimekizumab (genetical recombination)
Bimekizumab is a humanised IgG1/kappa monoclonal antibody that selectively binds with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. Elevated concentrations of IL-17A and IL-17F have been implicated in the pathogenesis of several immune-mediated inflammatory diseases including plaque psoriasis. Bimekizumab inhibits these proinflammatory cytokines, resulting in the normalization of skin inflammation and as a consequence improvement in clinical symptoms associated with psoriasis. From in vitro models, bimekizumab was shown to inhibit psoriasis-related gene expression and cytokine production to a greater extent than inhibition of IL-17A alone.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
5.70 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 20, 2021 EMA UCB Pharma S.A.
Jan. 20, 2022 PMDA UCB JAPAN CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product availability issue 229.54 29.14 52 2821 7352 90618222
Therapy interrupted 178.55 29.14 65 2808 50043 90575531
Oral candidiasis 160.61 29.14 55 2818 35400 90590174
Oesophageal candidiasis 158.84 29.14 38 2835 6791 90618783
Psoriatic arthropathy 130.20 29.14 84 2789 228251 90397323
Intentional dose omission 82.05 29.14 28 2845 17755 90607819
Surgery 78.71 29.14 35 2838 44852 90580722
Product dose omission issue 75.52 29.14 67 2806 291620 90333954
Candida infection 70.96 29.14 30 2843 34027 90591547
Injection site pain 66.16 29.14 50 2823 173649 90451925
Insurance issue 57.44 29.14 19 2854 10939 90614635
Product distribution issue 48.33 29.14 13 2860 3692 90621882
Inappropriate schedule of product administration 48.05 29.14 39 2834 149894 90475680
Incorrect dose administered 44.68 29.14 29 2844 78901 90546673
Off label use 41.92 29.14 101 2772 1102151 89523423
Drug ineffective 38.62 29.14 113 2760 1384185 89241389
Psoriasis area severity index increased 35.50 29.14 6 2867 182 90625392
Hidradenitis 33 29.14 10 2863 4337 90621237
Fungal infection 32.62 29.14 19 2854 42642 90582932
Therapeutic response shortened 31.20 29.14 15 2858 22864 90602710
Psoriasis 30.51 29.14 30 2843 147724 90477850

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product availability issue 226.47 40.87 46 1452 3521 42616316
Therapy interrupted 180.70 40.87 55 1443 22195 42597642
Psoriatic arthropathy 145.72 40.87 48 1450 24919 42594918
Oral candidiasis 105.71 40.87 33 1465 14372 42605465
Oesophageal candidiasis 86.73 40.87 23 1475 5612 42614225
Insurance issue 78.86 40.87 20 1478 4096 42615741
Product dose omission issue 54.02 40.87 44 1454 154321 42465516
Inappropriate schedule of product administration 52.99 40.87 36 1462 95866 42523971
Surgery 46.79 40.87 19 1479 17597 42602240
Psoriasis 41.30 40.87 24 1474 48580 42571257

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product dose omission issue 4795.89 35.66 1729 13095 320053 110254422
Product availability issue 2318.42 35.66 456 14368 7434 110567041
Therapy interrupted 782.79 35.66 282 14542 49540 110524935
Injection site pain 614.92 35.66 349 14475 177573 110396902
Insurance issue 583.74 35.66 157 14667 10455 110564020
Oral candidiasis 484.08 35.66 193 14631 44567 110529908
Inappropriate schedule of product administration 448.93 35.66 300 14524 203337 110371138
Condition aggravated 444.68 35.66 517 14307 734319 109840156
No adverse event 436.64 35.66 208 14616 73631 110500844
Incorrect dose administered 295.92 35.66 180 14644 103461 110471014
Candida infection 292.05 35.66 138 14686 47871 110526604
Drug ineffective 265.96 35.66 608 14216 1519932 109054543
Adverse drug reaction 245.39 35.66 161 14663 105398 110469077
Acne 233.89 35.66 106 14718 33414 110541061
Product distribution issue 228.09 35.66 62 14762 4284 110570191
Fungal infection 192.11 35.66 106 14718 50700 110523775
Device issue 190.91 35.66 93 14731 34442 110540033
Illness 190.09 35.66 125 14699 82046 110492429
Intentional dose omission 160.93 35.66 70 14754 20010 110554465
Psoriasis 138.86 35.66 129 14695 139864 110434611
Off label use 137.84 35.66 476 14348 1499709 109074766
Pruritus 137.16 35.66 264 14560 581296 109993179
Therapeutic response shortened 123.69 35.66 66 14758 29517 110544958
Oesophageal candidiasis 115.09 35.66 47 14777 11487 110562988
Device defective 113.40 35.66 35 14789 3787 110570688
Surgery 98.32 35.66 64 14760 41219 110533256
Injection site swelling 96.48 35.66 74 14750 61716 110512759
Device malfunction 95.67 35.66 53 14771 25505 110548970
Injection site reaction 84.27 35.66 80 14744 88990 110485485
Product leakage 79.86 35.66 22 14802 1596 110572879
Injection site pruritus 79.17 35.66 61 14763 51197 110523278
Psoriatic arthropathy 76.59 35.66 112 14712 196649 110377826
Injection site rash 70.13 35.66 42 14782 23377 110551098
Dyspnoea 66.22 35.66 33 14791 1106839 109467636
Acute kidney injury 63.47 35.66 6 14818 635424 109939051
Injection site erythema 60.93 35.66 69 14755 94107 110480368
Skin burning sensation 59.85 35.66 37 14787 21788 110552687
Hypotension 57.91 35.66 3 14821 523846 110050629
Anaemia 55.07 35.66 5 14819 547081 110027394
Skin disorder 53.37 35.66 45 14779 42868 110531607
Ear infection 53.05 35.66 53 14771 62679 110511796
Toxicity to various agents 52.34 35.66 3 14821 480552 110093923
Hidradenitis 51.30 35.66 21 14803 5159 110569316
Confusional state 50.82 35.66 3 14821 468677 110105798
Drug interaction 49.20 35.66 5 14819 500178 110074297
Pain 48.60 35.66 254 14570 954701 109619774
Therapeutic product effect incomplete 46.98 35.66 97 14727 223708 110350767
Loss of personal independence in daily activities 45.26 35.66 76 14748 149944 110424531
Rash 42.86 35.66 220 14604 820744 109753731
Vomiting 41.15 35.66 37 14787 910638 109663837
Drug intolerance 40.13 35.66 4 14820 406508 110167967
Nasopharyngitis 39.14 35.66 129 14695 394232 110180243
Neutropenia 38.84 35.66 3 14821 374617 110199858
Needle issue 38.45 35.66 26 14798 17814 110556661
Cyst 37.86 35.66 25 14799 16471 110558004

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC21 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs
anakinrabasiliximabbrodalumabcanakinumabdaclizumabguselkumabixekizumabmirikizumabrilonaceptrisankizumabsarilumabsatralizumab show all 18 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Plaque psoriasis indication 200965009
Pustular psoriasis indication 200973000
Erythrodermic psoriasis indication 200977004
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Upper respiratory tract infection contraindication 54150009
Oral candidiasis contraindication 79740000 DOID:14262
Active tuberculosis contraindication 427099000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Interleukin-17A Cytokine ANTIBODY BINDING Kd 11.46 DRUG LABEL DRUG LABEL
Interleukin-17F Cytokine ANTIBODY BINDING Kd 10.55 DRUG LABEL DRUG LABEL
Interleukin-17AF Cytokine ANTIBODY BINDING Kd 10.59 DRUG LABEL DRUG LABEL

External reference:

IDSource
09495UIM6V UNII
C4519734 UMLSCUI
CHEBI:757155 CHEBI
CHEMBL4297700 ChEMBL_ID
DB12917 DRUGBANK_ID
D11550 KEGG_DRUG
9878 INN_ID
C000625981 MESH_SUPPLEMENTAL_RECORD_UI
9411 IUPHAR_LIGAND_ID
1340107005 SNOMEDCT_US
278221000202100 SNOMEDCT_US
4042681 VANDF
39937 MMSL
d09814 MMSL
2668041 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bimzelx HUMAN PRESCRIPTION DRUG LABEL 1 50474-780 INJECTION, SOLUTION 160 mg SUBCUTANEOUS BLA 31 sections
Bimzelx HUMAN PRESCRIPTION DRUG LABEL 1 50474-781 INJECTION, SOLUTION 160 mg SUBCUTANEOUS BLA 31 sections
Bimzelx HUMAN PRESCRIPTION DRUG LABEL 1 50474-782 INJECTION, SOLUTION 320 mg SUBCUTANEOUS BLA 31 sections
Bimzelx HUMAN PRESCRIPTION DRUG LABEL 1 50474-783 INJECTION, SOLUTION 320 mg SUBCUTANEOUS BLA 31 sections