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Ofatumumab

January 01, 1970

Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion.[13] Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions.[9][11] Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States.[14] It is sold by Novartis under license from Genmab.[15]

Ofatumumab
Fragment antigen-binding of ofatumumab (PDB: 3GIZ​)
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetCD20
Clinical data
Trade namesArzerra, Kesimpta
Other namesHuMax-CD20, OMB157
AHFS/Drugs.comMonograph
MedlinePlusa621050
License data
Pregnancy
category
Routes of
administration		Intravenous (Arzerra), subcutaneous (Kesimpta)
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life14 days
Identifiers
CAS Number
  • 679818-59-8 N
DrugBank
  • DB06650 N
ChemSpider
  • none
UNII
  • M95KG522R0
KEGG
  • D09314
ChEMBL
  • ChEMBL1201836 N
Chemical and physical data
FormulaC6480H10022N1742O2020S44
Molar mass146062.27 g·mol−1
 NY (what is this?)  (verify)

The most common side effects for ofatumumab (Kesimpta) include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.[9] The most common side effects for ofatumumab (Arzerra) include infusion reactions and neutropenia.[14]

Medical uses edit

Ofatumumab (Kesimpta 20 mg solution for injection in pre-filled syringe/pen) is indicated for the treatment of relapsing forms of multiple sclerosis in adults.[9][11][16] The recommended dose is 20 mg of ofatumumab administered by subcutaneous injection with monthly dosing following loading.[17][18]

Treatment with ofatumumab has been shown to rapidly deplete B-cells[17][18] which aids MS pathogenesis by influencing and regulating different autoimmune process such as T-cell production and APC activity.[19] Depleted B-cells are required to address chronic clinical conditions like MS.

Ofatumumab (Arzerra 100 mg or 1000 mg concentrate for solution for infusion) is indicated for the treatment of untreated, relapsed, or refractory chronic lymphocytic leukemia (CLL).[8][20][6][21] The recommended doses for treatment of CLL are higher than MS, with 1000 or 2000 mg infusions administered monthly depending on if the CLL is untreated, relapsed or refractory, following loading.[21]

Ofatumumab is under investigation as a potential treatment for follicular lymphoma, diffuse large B cell lymphoma and rheumatoid arthritis.[citation needed]

Adverse effects edit

Adverse effects of ofatumumab (Kesimpta) by frequency:[22][18]

Very common (>10% frequency):

  • Upper respiratory tract infection
  • Injection-related reactions (systemic)
  • Injection-site reactions (local)
  • Urinary tract infections
  • Headache

Common (1-10% frequency):

  • Backpain
  • Blood immunoglobulin M decreased
  • Oral herpes

Adverse effects of ofatumumab (Arzerra) by frequency:[8][14][6]
Very common (>10% frequency):

  • Lower respiratory tract infection, including pneumonia
  • Upper respiratory tract infection
  • Rash
  • Anemia
  • Neutropenia
  • Dyspneoa
  • Cough
  • Nausea
  • Diarrhoea
  • Pyrexia
  • Fatigue
  • Bronchitis

Common (1-10% frequency):'

Uncommon (0.1-1% frequency):

Rare (<0.1% frequency):

Ofatumumab (Arzerra) has received a black box warning regarding the potential for it to cause progressive multifocal leukoencephalopathy and hepatitis B reactivation.[16][23] Likewise it is also advised that doctors watch cautiously for small bowel obstruction, neutropenia, thrombocytopenia, infusion reactions or an increased risk for infection.[23]

For more information, please refer to the prescribing information or your doctor.

Interactions edit

No formal drug interaction studies have been conducted with ofatumumab.[8] Although it is advised that patients are not administered live virus vaccines (e.g. the oral polio vaccine) while undergoing treatment with ofatumumab due to the compromised ability to fight the attenuated viruses seen in patients being treated with ofatumumab.[23] While on treatment with ofatumumab (Kesimpta), all immunizations should be administered according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ofatumumab for inactivated vaccines.[22]

Mechanism edit

Ofatumumab is a fully human anti-CD20 monoclonal antibody whose epitope is distinct from that of rituximab.[24] Ofatumumab binds to a distinct epitope on small and large extracellular loops of CD20.[25][26] The CD20 antigen is expressed on solely B cell lymphocytes.[24] Compared with rituximab, ofatumumab binds more tightly to CD20 with a slower off-rate.[24] It causes cytotoxicity in the cells that express CD20 by means of complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).[24]

History edit

Ofatumumab was jointly developed by Danish biotech Genmab and GlaxoSmithKline GSK plc who entered into an agreement to co-develop and commercialize ofatumumab in 2006.[27] It was approved as Arzerra for the treatment of chronic lymphocytic leukemia in the United States in October 2009.[28][29]

Ofatumumab (Arzerra) was then approved in the European Union in June 2010,[14] in the United Kingdom in April 2010,[6] and in Canada in August 2012.[30][31]

In 2014, Novartis acquired a number of GSK's oncology products, including the collaboration with Genmab and ofatumumab.[15][32]

For commercial reasons ofatumumab (Arzerra) was withdrawn from the Canadian market in 2017.[30][31] It was withdrawn from the European Union in February 2019.[33][34] Novartis removed it from all of the non-US markets and made it available only for compassionate use in those markets.[35][36]

Ofatumumab (Kesimpta) was approved for the treatment of relapsing forms of multiple sclerosis in adults in the United States in August 2020.[37][38] EU approval was subsequently received in March 2021.[11]

Society and culture edit

Economics edit

Ofatumumab (Arzerra) was transitioned to an oncology access program to make it available at no cost to chronic lymphocytic leukemia patients in the U.S.[39]

References edit

  1. ^ "Ofatumumab (Arzerra) Use During Pregnancy". Drugs.com. 29 January 2020. Retrieved 22 August 2020.
  2. ^ a b "AusPAR: Ofatumumab". Therapeutic Goods Administration (TGA). 19 August 2021. Retrieved 10 September 2021.
  3. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  4. ^ . Therapeutic Goods Administration (TGA). Archived from the original on 28 August 2021. Retrieved 23 August 2020.
  5. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  6. ^ a b c d . electronic Medicines Compendium. GlaxoSmithKline UK. 27 November 2013. Archived from the original on 4 March 2016. Retrieved 24 January 2014.
  7. ^ "Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL)". (emc). 14 April 2021. Retrieved 16 April 2021.
  8. ^ a b c d "Arzerra- ofatumumab injection, solution". DailyMed. 22 June 2020. Retrieved 21 August 2020.
  9. ^ a b c d "Kesimpta- ofatumumab injection, solution". DailyMed. 20 August 2020. Retrieved 23 August 2020.
  10. ^ "Arzerra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 21 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ^ a b c d "Kesimpta EPAR". European Medicines Agency (EMA). 25 January 2021. Retrieved 16 April 2021.
  12. ^ "Kesimpta Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  13. ^ Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, et al. (August 2020). "Ofatumumab versus Teriflunomide in Multiple Sclerosis". The New England Journal of Medicine. 383 (6): 546–557. doi:10.1056/nejmoa1917246. hdl:11573/1473907. PMID 32757523. S2CID 221015936.
  14. ^ a b c d (PDF). European Medicines Agency. 7 March 2013. Archived from the original (PDF) on 4 February 2014. Retrieved 24 January 2014.
  15. ^ a b "Genmab To Transfer Ofatumumab From GSK To Novartis". www.bioprocessonline.com. Retrieved 31 October 2022.
  16. ^ a b "Boxed Warning and new recommendations to decrease risk of hepatitis B". U.S. Food and Drug Administration. 21 June 2019. Retrieved 11 September 2021.
  17. ^ a b "Kesimpta EPAR" (PDF). European Medicines Agency (EMA). Retrieved 31 October 2022.
  18. ^ a b c "Prescribing Information Kesimpta" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 31 October 2022.
  19. ^ Arneth BM (June 2019). "Impact of B cells to the pathophysiology of multiple sclerosis". Journal of Neuroinflammation. 16 (1): 128. doi:10.1186/s12974-019-1517-1. PMC 6593488. PMID 31238945.
  20. ^ "Arzerra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 31 October 2022.
  21. ^ a b "Arzerra (ofatumumab) Information". U.S. Food and Drug Administration (FDA). 3 November 2018. Retrieved 31 October 2022.
  22. ^ a b "Kesimpta - Summary of Product Characteristics (SPC)" (PDF). European Medicines Agency (EMA). Retrieved 31 October 2022.
  23. ^ a b c "Arzerra (ofatumumab) dosing, indications, interactions, and more". Medscape Reference. WebMD. Retrieved 24 January 2014.
  24. ^ a b c d Lin TS (2010). "Ofatumumab: a novel monoclonal anti-CD20 antibody". Pharmacogenomics and Personalized Medicine. 3: 51–59. doi:10.2147/PGPM.S6840. PMC 3513208. PMID 23226042.
  25. ^ Anonymous Referee #2 (26 September 2016). "Interactive comment on "Sensitivity of the Variability of Mineral Aerosol Simulations to Meteorological Forcing Datasets" by Molly B. Smith et al". Atmospheric Chemistry and Physics. doi:10.5194/acp-2016-638-rc1.
  26. ^ Teeling JL, Mackus WJ, Wiegman LJ, van den Brakel JH, Beers SA, French RR, et al. (July 2006). "The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20". Journal of Immunology. 177 (1): 362–371. doi:10.4049/jimmunol.177.1.362. PMID 16785532. S2CID 24974085.
  27. ^ "Genmab - Global Agreement for Humax-CD20". Genmab - Global Agreement for Humax-CD20. Retrieved 31 October 2022.
  28. ^ "Drug Approval Package:Arzerra (Ofatumumab) Injection Application: 125326". U.S. Food and Drug Administration (FDA). 21 January 2010. Retrieved 21 August 2020.
  29. ^ "Arzerra (ofatumumab) FDA Approval History". Drugs.com. 26 October 2009. Retrieved 21 August 2020.
  30. ^ a b "Arzerra Product information 86740". Drug Product Database. 25 April 2012. Retrieved 21 August 2020.
  31. ^ a b "Arzerra Product information 86741". Drug Product Database. 25 April 2012. Retrieved 21 August 2020.
  32. ^ "GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis". GSK (Press release). Retrieved 31 October 2022.
  33. ^ "Arzerra: Withdrawn application". European Medicines Agency (EMA). 17 September 2018. Retrieved 21 August 2020.
  34. ^ "Arzerra: Withdrawal of the marketing authorisation in the European Union" (PDF). European Medicines Agency. 28 February 2019.
  35. ^ "Novartis Withdraws Chronic Leukemia Drug Arzerra From Non-U.S. Markets". FDANews. 30 January 2018. Retrieved 21 August 2020.
  36. ^ "Novartis to transition use of Arzerra to compassionate use outside US". EPM Magazine. 22 January 2018. Retrieved 21 August 2020.
  37. ^ "FDA approves Novartis Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis" (Press release). Novartis. 20 August 2020. Retrieved 21 August 2020.
  38. ^ "Ofatumumab (Kesimpta) FDA approval letter" (PDF).
  39. ^ "Genmab Announces Plan to Transition Arzerra (ofatumumab) to an Oncology Access Program for Chronic Lymphocytic Leukemia Patients in the U.S. Copenhagen Stock Exchange:GEN" (Press release). Genmab A/S. 20 August 2020. Retrieved 16 April 2021 – via GlobeNewswire.

Further reading edit

  • Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, et al. (February 2008). "Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study". Blood. 111 (3): 1094–1100. doi:10.1182/blood-2007-09-111781. PMID 18003886. S2CID 22333805.
  • Zhang B (July 2009). "Ofatumumab". mAbs. 1 (4): 326–331. doi:10.4161/mabs.1.4.8895. PMC 2726602. PMID 20068404.

External links edit

  • Clinical trial number NCT01848145 for "Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia" at ClinicalTrials.gov

January 01, 1970
ofatumumab, fully, human, monoclonal, antibody, cd20, which, appears, provide, rapid, cell, depletion, under, brand, name, kesimpta, approved, treatment, multiple, sclerosis, united, states, well, european, union, other, regions, under, brand, name, arzerra, a. Ofatumumab is a fully human monoclonal antibody to CD20 which appears to provide rapid B cell depletion 13 Under the brand name Kesimpta it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions 9 11 Under the brand name Arzerra it is approved for the treatment of certain types of chronic lymphocytic leukemia CLL in the United States 14 It is sold by Novartis under license from Genmab 15 OfatumumabFragment antigen binding of ofatumumab PDB 3GIZ Monoclonal antibodyTypeWhole antibodySourceHumanTargetCD20Clinical dataTrade namesArzerra KesimptaOther namesHuMax CD20 OMB157AHFS Drugs comMonographMedlinePlusa621050License dataUS DailyMed OfatumumabPregnancycategoryAU C 1 2 Routes ofadministrationIntravenous Arzerra subcutaneous Kesimpta ATC codeL01FA02 WHO Arzerra L04AG12 WHO Kesimpta Legal statusLegal statusAU S4 Prescription only 4 2 CA only Schedule D 5 UK POM Prescription only 6 7 US WARNING 3 Rx only 8 9 EU Rx only 10 11 12 In general Prescription only Pharmacokinetic dataElimination half life14 daysIdentifiersCAS Number679818 59 8 NDrugBankDB06650 NChemSpidernoneUNIIM95KG522R0KEGGD09314ChEMBLChEMBL1201836 NChemical and physical dataFormulaC 6480H 10022N 1742O 2020S 44Molar mass146062 27 g mol 1 N Y what is this verify The most common side effects for ofatumumab Kesimpta include upper respiratory tract infection headache injection related reactions and local injection site reactions 9 The most common side effects for ofatumumab Arzerra include infusion reactions and neutropenia 14 Contents 1 Medical uses 2 Adverse effects 3 Interactions 4 Mechanism 5 History 6 Society and culture 6 1 Economics 7 References 8 Further reading 9 External linksMedical uses editOfatumumab Kesimpta 20 mg solution for injection in pre filled syringe pen is indicated for the treatment of relapsing forms of multiple sclerosis in adults 9 11 16 The recommended dose is 20 mg of ofatumumab administered by subcutaneous injection with monthly dosing following loading 17 18 Treatment with ofatumumab has been shown to rapidly deplete B cells 17 18 which aids MS pathogenesis by influencing and regulating different autoimmune process such as T cell production and APC activity 19 Depleted B cells are required to address chronic clinical conditions like MS Ofatumumab Arzerra 100 mg or 1000 mg concentrate for solution for infusion is indicated for the treatment of untreated relapsed or refractory chronic lymphocytic leukemia CLL 8 20 6 21 The recommended doses for treatment of CLL are higher than MS with 1000 or 2000 mg infusions administered monthly depending on if the CLL is untreated relapsed or refractory following loading 21 Ofatumumab is under investigation as a potential treatment for follicular lymphoma diffuse large B cell lymphoma and rheumatoid arthritis citation needed Adverse effects editAdverse effects of ofatumumab Kesimpta by frequency 22 18 Very common gt 10 frequency Upper respiratory tract infection Injection related reactions systemic Injection site reactions local Urinary tract infections Headache Common 1 10 frequency Backpain Blood immunoglobulin M decreased Oral herpes Adverse effects of ofatumumab Arzerra by frequency 8 14 6 Very common gt 10 frequency Lower respiratory tract infection including pneumonia Upper respiratory tract infection Rash Anemia Neutropenia Dyspneoa Cough Nausea Diarrhoea Pyrexia Fatigue Bronchitis Common 1 10 frequency Cytopnia Sepsis Infusion reaction Herpes virus infection Urinary tract infection Febrile neutropenia Leucopenia Thrombocytopenia Anaphylactoid reactions Hypersensitivity Headache Tachycardia Hypotension Hypertension Bronchospasm Hypoxia Chest discomfort Pharyngolaryngeal pain Nasal congestion Small bowel obstruction Itchiness Flushing Back pain Cytokine release syndrome Rigors Chills Hyperhidrosis Uncommon 0 1 1 frequency Agranulocytosis Bradycardia Hepatitis B infection and reactivation Coagulopathy Red cell aplasia Lymphopenia Anaphylactic reactions Tumour lysis syndrome Rare lt 0 1 frequency Hepatitis B infection or reactivation Ofatumumab Arzerra has received a black box warning regarding the potential for it to cause progressive multifocal leukoencephalopathy and hepatitis B reactivation 16 23 Likewise it is also advised that doctors watch cautiously for small bowel obstruction neutropenia thrombocytopenia infusion reactions or an increased risk for infection 23 For more information please refer to the prescribing information or your doctor Interactions editNo formal drug interaction studies have been conducted with ofatumumab 8 Although it is advised that patients are not administered live virus vaccines e g the oral polio vaccine while undergoing treatment with ofatumumab due to the compromised ability to fight the attenuated viruses seen in patients being treated with ofatumumab 23 While on treatment with ofatumumab Kesimpta all immunizations should be administered according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab for live or live attenuated vaccines and whenever possible at least 2 weeks prior to initiation of ofatumumab for inactivated vaccines 22 Mechanism editOfatumumab is a fully human anti CD20 monoclonal antibody whose epitope is distinct from that of rituximab 24 Ofatumumab binds to a distinct epitope on small and large extracellular loops of CD20 25 26 The CD20 antigen is expressed on solely B cell lymphocytes 24 Compared with rituximab ofatumumab binds more tightly to CD20 with a slower off rate 24 It causes cytotoxicity in the cells that express CD20 by means of complement dependent cytotoxicity CDC and antibody dependent cellular cytotoxicity ADCC 24 History editOfatumumab was jointly developed by Danish biotech Genmab and GlaxoSmithKline GSK plc who entered into an agreement to co develop and commercialize ofatumumab in 2006 27 It was approved as Arzerra for the treatment of chronic lymphocytic leukemia in the United States in October 2009 28 29 Ofatumumab Arzerra was then approved in the European Union in June 2010 14 in the United Kingdom in April 2010 6 and in Canada in August 2012 30 31 In 2014 Novartis acquired a number of GSK s oncology products including the collaboration with Genmab and ofatumumab 15 32 For commercial reasons ofatumumab Arzerra was withdrawn from the Canadian market in 2017 30 31 It was withdrawn from the European Union in February 2019 33 34 Novartis removed it from all of the non US markets and made it available only for compassionate use in those markets 35 36 Ofatumumab Kesimpta was approved for the treatment of relapsing forms of multiple sclerosis in adults in the United States in August 2020 37 38 EU approval was subsequently received in March 2021 11 Society and culture editEconomics edit Ofatumumab Arzerra was transitioned to an oncology access program to make it available at no cost to chronic lymphocytic leukemia patients in the U S 39 References edit Ofatumumab Arzerra Use During Pregnancy Drugs com 29 January 2020 Retrieved 22 August 2020 a b AusPAR Ofatumumab Therapeutic Goods Administration TGA 19 August 2021 Retrieved 10 September 2021 FDA sourced list of all drugs with black box warnings Use Download Full Results and View Query links nctr crs fda gov FDA Retrieved 22 October 2023 Summary for ARTG Entry 196945 Arzerra ofatumumab rmc 100mg 5mL injection concentrate vial Therapeutic Goods Administration TGA Archived from the original on 28 August 2021 Retrieved 23 August 2020 Health product highlights 2021 Annexes of products approved in 2021 Health Canada 3 August 2022 Retrieved 25 March 2024 a b c d Arzerra acetate formulation Summary of Product Characteristics SPC electronic Medicines Compendium GlaxoSmithKline UK 27 November 2013 Archived from the original on 4 March 2016 Retrieved 24 January 2014 Kesimpta 20 mg solution for injection in pre filled pen Patient Information Leaflet PIL emc 14 April 2021 Retrieved 16 April 2021 a b c d Arzerra ofatumumab injection solution DailyMed 22 June 2020 Retrieved 21 August 2020 a b c d Kesimpta ofatumumab injection solution DailyMed 20 August 2020 Retrieved 23 August 2020 Arzerra EPAR European Medicines Agency EMA 17 September 2018 Retrieved 21 August 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b c d Kesimpta EPAR European Medicines Agency EMA 25 January 2021 Retrieved 16 April 2021 Kesimpta Product information Union Register of medicinal products Retrieved 3 March 2023 Hauser SL Bar Or A Cohen JA Comi G Correale J Coyle PK et al August 2020 Ofatumumab versus Teriflunomide in Multiple Sclerosis The New England Journal of Medicine 383 6 546 557 doi 10 1056 nejmoa1917246 hdl 11573 1473907 PMID 32757523 S2CID 221015936 a b c d Arzerra EPAR Product Information PDF European Medicines Agency 7 March 2013 Archived from the original PDF on 4 February 2014 Retrieved 24 January 2014 a b Genmab To Transfer Ofatumumab From GSK To Novartis www bioprocessonline com Retrieved 31 October 2022 a b Boxed Warning and new recommendations to decrease risk of hepatitis B U S Food and Drug Administration 21 June 2019 Retrieved 11 September 2021 a b Kesimpta EPAR PDF European Medicines Agency EMA Retrieved 31 October 2022 a b c Prescribing Information Kesimpta PDF U S Food and Drug Administration FDA Retrieved 31 October 2022 Arneth BM June 2019 Impact of B cells to the pathophysiology of multiple sclerosis Journal of Neuroinflammation 16 1 128 doi 10 1186 s12974 019 1517 1 PMC 6593488 PMID 31238945 Arzerra EPAR European Medicines Agency EMA 17 September 2018 Retrieved 31 October 2022 a b Arzerra ofatumumab Information U S Food and Drug Administration FDA 3 November 2018 Retrieved 31 October 2022 a b Kesimpta Summary of Product Characteristics SPC PDF European Medicines Agency EMA Retrieved 31 October 2022 a b c Arzerra ofatumumab dosing indications interactions and more Medscape Reference WebMD Retrieved 24 January 2014 a b c d Lin TS 2010 Ofatumumab a novel monoclonal anti CD20 antibody Pharmacogenomics and Personalized Medicine 3 51 59 doi 10 2147 PGPM S6840 PMC 3513208 PMID 23226042 Anonymous Referee 2 26 September 2016 Interactive comment on Sensitivity of the Variability of Mineral Aerosol Simulations to Meteorological Forcing Datasets by Molly B Smith et al Atmospheric Chemistry and Physics doi 10 5194 acp 2016 638 rc1 Teeling JL Mackus WJ Wiegman LJ van den Brakel JH Beers SA French RR et al July 2006 The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20 Journal of Immunology 177 1 362 371 doi 10 4049 jimmunol 177 1 362 PMID 16785532 S2CID 24974085 Genmab Global Agreement for Humax CD20 Genmab Global Agreement for Humax CD20 Retrieved 31 October 2022 Drug Approval Package Arzerra Ofatumumab Injection Application 125326 U S Food and Drug Administration FDA 21 January 2010 Retrieved 21 August 2020 Arzerra ofatumumab FDA Approval History Drugs com 26 October 2009 Retrieved 21 August 2020 a b Arzerra Product information 86740 Drug Product Database 25 April 2012 Retrieved 21 August 2020 a b Arzerra Product information 86741 Drug Product Database 25 April 2012 Retrieved 21 August 2020 GSK completes divestment of rights to ofatumumab for auto immune indications to Novartis GSK Press release Retrieved 31 October 2022 Arzerra Withdrawn application European Medicines Agency EMA 17 September 2018 Retrieved 21 August 2020 Arzerra Withdrawal of the marketing authorisation in the European Union PDF European Medicines Agency 28 February 2019 Novartis Withdraws Chronic Leukemia Drug Arzerra From Non U S Markets FDANews 30 January 2018 Retrieved 21 August 2020 Novartis to transition use of Arzerra to compassionate use outside US EPM Magazine 22 January 2018 Retrieved 21 August 2020 FDA approves Novartis Kesimpta ofatumumab the first and only self administered targeted B cell therapy for patients with relapsing multiple sclerosis Press release Novartis 20 August 2020 Retrieved 21 August 2020 Ofatumumab Kesimpta FDA approval letter PDF Genmab Announces Plan to Transition Arzerra ofatumumab to an Oncology Access Program for Chronic Lymphocytic Leukemia Patients in the U S Copenhagen Stock Exchange GEN Press release Genmab A S 20 August 2020 Retrieved 16 April 2021 via GlobeNewswire Further reading editCoiffier B Lepretre S Pedersen LM Gadeberg O Fredriksen H van Oers MH et al February 2008 Safety and efficacy of ofatumumab a fully human monoclonal anti CD20 antibody in patients with relapsed or refractory B cell chronic lymphocytic leukemia a phase 1 2 study Blood 111 3 1094 1100 doi 10 1182 blood 2007 09 111781 PMID 18003886 S2CID 22333805 Zhang B July 2009 Ofatumumab mAbs 1 4 326 331 doi 10 4161 mabs 1 4 8895 PMC 2726602 PMID 20068404 External links editClinical trial number NCT01848145 for Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia at ClinicalTrials gov Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Ofatumumab amp oldid 1215620691, wikipedia, wiki, book, books, library,

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