Ofatumumab: Difference between revisions

{{Short description|Medication}}

{{Use dmy dates|date=November 2022}}

{{cs1 config |name-list-style=vanc |display-authors=6}}

{{Infobox drug

| Verifiedfields = changed

| Watchedfields = changed

| verifiedrevid = 458269271

| type = mab

| image = Ofatumumab_3GIZ.png

| width =

| alt =

| caption = [[Fragment antigen-binding]] of ofatumumab ({{PDB|3GIZ}})

<!-- Monoclonal antibody data -->

| mab_type = mab

| source = u

| target = [[CD20]]

<!-- Clinical data -->

| pronounce =

| tradename = Arzerra, Kesimpta

| Drugs.com = {{drugs.com|monograph|ofatumumab}}

| MedlinePlus = a621050

| DailyMedID = Ofatumumab

| pregnancy_AU = C

| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Ofatumumab (Arzerra) Use During Pregnancy | website=Drugs.com | date=29 January 2020 | url=https://www.drugs.com/pregnancy/ofatumumab.html | access-date=22 August 2020 | archive-date=29 November 2020 | archive-url=https://web.archive.org/web/20201129175619/https://www.drugs.com/pregnancy/ofatumumab.html | url-status=live }}</ref><ref name="AusPAR: Ofatumumab">{{cite web | title=AusPAR: Ofatumumab | website=Therapeutic Goods Administration (TGA) | date=19 August 2021 | url=https://www.tga.gov.au/auspar/auspar-ofatumumab-1 | access-date=10 September 2021 | archive-date=11 September 2021 | archive-url=https://web.archive.org/web/20210911203707/https://www.tga.gov.au/auspar/auspar-ofatumumab-1 | url-status=live }}</ref>

| pregnancy_category =

| routes_of_administration = [[Intravenous therapy|Intravenous]] (Arzerra), [[Subcutaneous injection|subcutaneous]] (Kesimpta)

| class =

| ATCvet =

| ATC_prefix =

| ATC_suffix =

| ATC_supplemental = {{ATC|L01|FA02}} (Arzerra), {{ATC|L04|AG12}} (Kesimpta)

<!-- Legal status -->

| legal_AU = S4

| legal_AU_comment = <ref>{{cite web | title=Summary for ARTG Entry:196945 Arzerra ofatumumab (rmc) 100mg/5mL injection concentrate vial | website=[[Therapeutic Goods Administration]] (TGA) | url=http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs%2FPublicHTML%2FpdfStore.nsf&docid=E4D17326E33C9A02CA2585880030C3A5&agid=%28PrintDetailsPublic%29&actionid=1 | access-date=23 August 2020 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828194420/https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs%2FPublicHTML%2FpdfStore.nsf&docid=E4D17326E33C9A02CA2585880030C3A5&agid=%28PrintDetailsPublic%29&actionid=1 | url-status=dead }}</ref><ref name="AusPAR: Ofatumumab" />

| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->

| legal_BR_comment =

| legal_CA = Rx-only

| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Health product highlights 2021: Annexes of products approved in 2021 | website=[[Health Canada]] | date=3 August 2022 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | access-date=25 March 2024 | archive-date=25 March 2024 | archive-url=https://web.archive.org/web/20240325234307/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | url-status=live }}</ref>

| legal_DE = <!-- Anlage I, II, III or Unscheduled -->

| legal_DE_comment =

| legal_NZ = <!-- Class A, B, C -->

| legal_NZ_comment =

| legal_UK = POM

| legal_UK_comment = <ref name = EMC/><ref>{{cite web | title=Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL) | website=(emc) | date=14 April 2021 | url=https://www.medicines.org.uk/emc/product/12433 | access-date=16 April 2021 | archive-date=16 April 2021 | archive-url=https://web.archive.org/web/20210416192303/https://www.medicines.org.uk/emc/product/12433 | url-status=live }}</ref>

| legal_US = Rx-only

| legal_US_comment = <ref name="Arzerra FDA label" /><ref name="Kesimpta FDA label" />

| legal_EU = Rx-only

| legal_EU_comment = <ref name="Arzerra EPAR">{{cite web | title=Arzerra EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra | access-date=21 August 2020 | archive-date=8 August 2020 | archive-url=https://web.archive.org/web/20200808124807/https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="Kesimpta EPAR" /><ref>{{cite web | title=Kesimpta Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1532.htm | access-date=3 March 2023 | archive-date=5 March 2023 | archive-url=https://web.archive.org/web/20230305043803/https://ec.europa.eu/health/documents/community-register/html/h1532.htm | url-status=live }}</ref>

| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->

| legal_UN_comment =

| legal_status = Rx-only

<!-- Pharmacokinetic data -->

| bioavailability =

| protein_bound =

| metabolism =

| metabolites =

| >

| elimination_half-life = 14 days

| duration_of_action =

| excretion =

<!-- Identifiers -->

| CAS_number_Ref = {{cascite|changed|??}}

| CAS_number = 679818-59-8

| PubChem =

| IUPHAR_ligand =

| DrugBank_Ref = {{drugbankcite|changed|drugbank}}

| DrugBank = DB06650

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = M95KG522R0

| KEGG_Ref =

| KEGG = D09314

| ChEBI_Ref =

| ChEBI =

| ChEMBL_Ref = {{ebicite|changed|EBI}}

| ChEMBL = 1201836

| NIAID_ChemDB =

| PDB_ligand =

| synonyms = HuMax-CD20, OMB157

<!-- Chemical and physical data -->

| C = 6480

| H = 10022

| N = 1742

| O = 2020

| S = 44

'''Ofatumumab''' is a fully [[human monoclonal antibody]] to [[CD20]], which appears to provide rapid [[B-cell]] depletion.<ref>{{cite journal | vauthors = Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L | title = Ofatumumab versus Teriflunomide in Multiple Sclerosis | journal = The New England Journal of Medicine | volume = 383 | issue = 6 | pages = 546–557 | date = August 2020 | pmid = 32757523 | doi = 10.1056/nejmoa1917246 | s2cid = 221015936 | doi-access = free | hdl = 11573/1473907 | hdl-access = free }}</ref> 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.<ref name="Kesimpta FDA label">{{cite web |date=20 August 2020 |title=Kesimpta- ofatumumab injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a8a3f53-2062-48ff-9dbe-b939df133ca3 |access-date=23 August 2020 |website=DailyMed |archive-date=14 February 2021 |archive-url=https://web.archive.org/web/20210214173004/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a8a3f53-2062-48ff-9dbe-b939df133ca3 |url-status=live }}</ref><ref name="Kesimpta EPAR">{{cite web |date=25 January 2021 |title=Kesimpta EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/kesimpta |access-date=16 April 2021 |website=[[European Medicines Agency]] (EMA) |archive-date=16 April 2021 |archive-url=https://web.archive.org/web/20210416192304/https://www.ema.europa.eu/en/medicines/human/EPAR/kesimpta |url-status=live }}</ref> Under the brand name '''Arzerra''', it is approved for the treatment of certain types of [[chronic lymphocytic leukemia]] (CLL) in the United States.<ref name="EMA">{{cite web |date=7 March 2013 |title=Arzerra : EPAR - Product Information |url=http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001131/WC500093091.pdf |access-date=24 January 2014 |work=European Medicines Agency |archive-date=4 February 2014 |archive-url=https://web.archive.org/web/20140204001532/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001131/WC500093091.pdf |url-status=dead }}</ref> It is sold by [[Novartis]] under license from [[Genmab]].<ref name="Genmab" />

The most common side effects for ofatumumab (Kesimpta) include [[upper respiratory tract infection]], [[headache]], injection-related reactions, and local [[injection site reaction]]s.<ref name="Kesimpta FDA label" /> The most common side effects for ofatumumab (Arzerra) include [[infusion reaction]]s and [[neutropenia]].<ref name="EMA" />

==Medical uses==

Ofatumumab (Kesimpta 20&nbsp;mg solution for injection in pre-filled syringe/pen) is indicated for the treatment of relapsing forms of [[multiple sclerosis]] in adults.<ref name="Kesimpta FDA label" /><ref name="Kesimpta EPAR" /><ref name=":0" /> The recommended dose is 20&nbsp;mg of ofatumumab administered by subcutaneous injection with monthly dosing following loading.<ref name=":1">{{cite web |title=Kesimpta EPAR |url=https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf |access-date=31 October 2022 |website=European Medicines Agency (EMA) |archive-date=21 October 2022 |archive-url=https://web.archive.org/web/20221021151747/https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf |url-status=live }}</ref><ref name=":2">{{cite web |title=Prescribing Information Kesimpta |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf |access-date=31 October 2022 |website=U.S. Food and Drug Administration (FDA) |archive-date=22 April 2022 |archive-url=https://web.archive.org/web/20220422100350/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf |url-status=live }}</ref>

Treatment with ofatumumab has been shown to rapidly deplete B-cells<ref name=":1" /><ref name=":2" /> which aids MS pathogenesis by influencing and regulating different autoimmune process such as T-cell production and APC activity.<ref>{{cite journal | vauthors = Arneth BM | title = Impact of B cells to the pathophysiology of multiple sclerosis | journal = Journal of Neuroinflammation | volume = 16 | issue = 1 | pages = 128 | date = June 2019 | pmid = 31238945 | pmc = 6593488 | doi = 10.1186/s12974-019-1517-1 | doi-access = free }}</ref> Depleted B-cells are required to address chronic clinical conditions like MS.

Ofatumumab (Arzerra 100&nbsp;mg or 1000&nbsp;mg concentrate for solution for infusion) is indicated for the treatment of untreated, relapsed, or refractory [[chronic lymphocytic leukemia]] (CLL).<ref name="Arzerra FDA label">{{cite web |date=22 June 2020 |title=Arzerra- ofatumumab injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77785ce3-e8df-4ca1-8f8e-6c418c6a17de |access-date=21 August 2020 |website=DailyMed |archive-date=14 February 2021 |archive-url=https://web.archive.org/web/20210214094322/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77785ce3-e8df-4ca1-8f8e-6c418c6a17de |url-status=live }}</ref><ref>{{cite web |title=Arzerra EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra |access-date=31 October 2022 |website=European Medicines Agency (EMA) |date=17 September 2018 |archive-date=8 August 2020 |archive-url=https://web.archive.org/web/20200808124807/https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra |url-status=live }}</ref><ref name="EMC">{{cite web |date=27 November 2013 |title=Arzerra (acetate formulation) -Summary of Product Characteristics (SPC) |url=http://www.medicines.org.uk/emc/medicine/23022/SPC/Arzerra+(acetate+formulation)/ |url-status=dead |archive-url=https://web.archive.org/web/20160304055033/http://www.medicines.org.uk/emc/medicine/23022/SPC/Arzerra+(acetate+formulation)/ |archive-date=4 March 2016 |access-date=24 January 2014 |work=electronic Medicines Compendium |publisher=GlaxoSmithKline UK}}</ref><ref name=":3">{{cite web |title=Arzerra (ofatumumab) Information |url=https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/arzerra-ofatumumab-information |access-date=31 October 2022 |website=U.S. Food and Drug Administration (FDA) |date=3 November 2018 |archive-date=31 October 2022 |archive-url=https://web.archive.org/web/20221031143043/https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/arzerra-ofatumumab-information |url-status=live }}</ref> The recommended doses for treatment of CLL are higher than MS, with 1000 or 2000&nbsp;mg infusions administered monthly depending on if the CLL is untreated, relapsed or refractory, following loading.<ref name=":3" />

Ofatumumab is under investigation as a potential treatment for [[follicular lymphoma]], [[diffuse large B cell lymphoma]] and [[rheumatoid arthritis]].{{citation needed|date=April 2022}}

==Adverse effects==

'''Adverse effects of ofatumumab (Kesimpta) by frequency:'''<ref name=":4">{{cite web |title=Kesimpta - Summary of Product Characteristics (SPC) |url=https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf |access-date=31 October 2022 |website=European Medicines Agency (EMA) |archive-date=21 October 2022 |archive-url=https://web.archive.org/web/20221021151747/https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf |url-status=live }}</ref><ref name=":2" />

'''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

'''<big>Adverse effects of ofatumumab (Arzerra) by frequency:</big>'''<ref name="Arzerra FDA label" /><ref name="EMA" /><ref name="EMC" /><br>

'''Very common (>10% frequency):'''

{{div col|colwidth=22em}}

* Lower respiratory tract infection, including [[pneumonia]]

* Upper respiratory tract infection

* Rash

* [[Anemia]]

* [[Neutropenia]]

* Dyspneoa

* Cough

* Nausea

* Diarrhoea

* Pyrexia

* Fatigue

* Bronchitis

{{div col end}}

'''Common (1-10% frequency):''''

{{div col|colwidth=15em}}

* 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{{div col end}}

'''Uncommon (0.1-1% frequency):'''

{{div col|colwidth=18em}}

* [[Agranulocytosis]]

* Bradycardia

* Hepatitis B infection and reactivation

* Coagulopathy

* Red cell aplasia

* [[Lymphopenia]]

* Anaphylactic reactions

* [[Tumour lysis syndrome]]

{{div col end}}

'''Rare (<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.<ref name=":0">{{cite web | title=Boxed Warning and new recommendations to decrease risk of hepatitis B | website=U.S. Food and Drug Administration | date=21 June 2019 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-boxed-warning-and-new-recommendations-decrease-risk-hepatitis-b | access-date=11 September 2021 | archive-date=28 April 2020 | archive-url=https://web.archive.org/web/20200428213737/https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-boxed-warning-and-new-recommendations-decrease-risk-hepatitis-b | url-status=live }}</ref><ref name = MSR>{{cite web|title=Arzerra (ofatumumab) dosing, indications, interactions, and more|work=Medscape Reference|publisher=WebMD|access-date=24 January 2014|url=http://reference.medscape.com/drug/arzerra-ofatumumab-999309#showall|archive-date=2 February 2014|archive-url=https://web.archive.org/web/20140202174741/http://reference.medscape.com/drug/arzerra-ofatumumab-999309#showall|url-status=live}}</ref> Likewise it is also advised that doctors watch cautiously for small bowel obstruction, neutropenia, thrombocytopenia, infusion reactions or an increased risk for infection.<ref name = MSR/>

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

==Interactions ==

No formal drug interaction studies have been conducted with ofatumumab.<ref name = "Arzerra FDA label" /> 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.<ref name = MSR/> 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.<ref name=":4" />

Ofatumumab is a fully human anti-[[CD20]] monoclonal antibody whose epitope is distinct from that of [[rituximab]].<ref name = Mech>{{cite journal | vauthors = Lin TS | title = Ofatumumab: a novel monoclonal anti-CD20 antibody | journal = Pharmacogenomics and Personalized Medicine | volume = 3 | pages = 51–59 | date = 2010 | pmid = 23226042 | pmc = 3513208 | doi = 10.2147/PGPM.S6840 | doi-access = free }}</ref> Ofatumumab binds to a distinct epitope on small and large extracellular loops of CD20.<ref>{{cite journal | vauthors = ((Anonymous Referee #2)) |title=Interactive comment on "Sensitivity of the Variability of Mineral Aerosol Simulations to Meteorological Forcing Datasets" by Molly B. Smith et al. | journal = Atmospheric Chemistry and Physics |doi=10.5194/acp-2016-638-rc1 | date = 26 September 2016 |doi-access=free }}</ref><ref>{{cite journal | vauthors = Teeling JL, Mackus WJ, Wiegman LJ, van den Brakel JH, Beers SA, French RR, van Meerten T, Ebeling S, Vink T, Slootstra JW, Parren PW, Glennie MJ, van de Winkel JG | title = The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20 | journal = Journal of Immunology | volume = 177 | issue = 1 | pages = 362–371 | date = July 2006 | pmid = 16785532 | doi = 10.4049/jimmunol.177.1.362 | s2cid = 24974085 | doi-access = free }}</ref> The CD20 antigen is expressed on solely B cell lymphocytes.<ref name = Mech/> Compared with rituximab, ofatumumab binds more tightly to CD20 with a slower off-rate.<ref name = Mech/> It causes cytotoxicity in the cells that express CD20 by means of [[complement-dependent cytotoxicity]] (CDC) and [[antibody-dependent cellular cytotoxicity]] (ADCC).<ref name = Mech/>

==History==

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.<ref>{{cite web |title=Genmab - Global Agreement for Humax-CD20 |url=https://ir.genmab.com/static-files/0ed47252-19fa-4599-b9d8-0c5b6389aff5 |access-date=31 October 2022 |website=Genmab - Global Agreement for Humax-CD20}}</ref> It was approved as Arzerra for the treatment of chronic lymphocytic leukemia in the United States in October 2009.<ref>{{cite web | title=Drug Approval Package:Arzerra (Ofatumumab) Injection Application: 125326 | website=U.S. [[Food and Drug Administration]] (FDA) | date=21 January 2010 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm | access-date=21 August 2020 | archive-date=10 April 2021 | archive-url=https://web.archive.org/web/20210410061251/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm | url-status=live }}</ref><ref>{{cite web | title=Arzerra (ofatumumab) FDA Approval History | website=Drugs.com | date=26 October 2009 | url=https://www.drugs.com/history/arzerra.html | access-date=21 August 2020 | archive-date=1 September 2020 | archive-url=https://web.archive.org/web/20200901192631/https://www.drugs.com/history/arzerra.html | url-status=live }}</ref>

Ofatumumab (Arzerra) was then approved in the European Union in June 2010,<ref name = EMA/> in the United Kingdom in April 2010,<ref name="EMC" /> and in Canada in August 2012.<ref name=HC>{{cite web | title=Arzerra Product information 86740 | website=Drug Product Database | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=86740 | access-date=21 August 2020 | archive-date=22 August 2020 | archive-url=https://web.archive.org/web/20200822035512/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=86740 | url-status=live }}</ref><ref name="HC 2">{{cite web | title=Arzerra Product information 86741 | website=Drug Product Database | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=86741 | access-date=21 August 2020 | archive-date=22 August 2020 | archive-url=https://web.archive.org/web/20200822035513/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=86741 | url-status=live }}</ref>

In 2014, Novartis acquired a number of GSK's oncology products, including the collaboration with Genmab and ofatumumab.<ref name="Genmab">{{cite web |title=Genmab To Transfer Ofatumumab From GSK To Novartis |url=https://www.bioprocessonline.com/doc/genmab-to-transfer-ofatumumab-from-gsk-to-novartis-0001 |access-date=31 October 2022 |website=www.bioprocessonline.com |archive-date=29 September 2022 |archive-url=https://web.archive.org/web/20220929002152/https://www.bioprocessonline.com/doc/genmab-to-transfer-ofatumumab-from-gsk-to-novartis-0001 |url-status=live }}</ref><ref>{{cite press release |title=GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis |url=https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/ |access-date=31 October 2022 |website=GSK |archive-date=7 October 2022 |archive-url=https://web.archive.org/web/20221007221718/https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/ |url-status=live }}</ref>

For commercial reasons ofatumumab (Arzerra) was withdrawn from the Canadian market in 2017.<ref name="HC" /><ref name="HC 2" /> It was withdrawn from the European Union in February 2019.<ref>{{cite web | title=Arzerra: Withdrawn application | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/arzerra | access-date=21 August 2020 | archive-date=28 October 2020 | archive-url=https://web.archive.org/web/20201028154623/https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/arzerra | url-status=live }}</ref><ref>{{cite web | title = Arzerra: Withdrawal of the marketing authorisation in the European Union | publisher = European Medicines Agency | date = 28 February 2019 | url = https://www.ema.europa.eu/documents/public-statement/public-statement-arzerra-withdrawal-marketing-authorisation-european-union_en.pdf | access-date = 21 August 2020 | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828194419/https://www.ema.europa.eu/en/documents/public-statement/public-statement-arzerra-withdrawal-marketing-authorisation-european-union_en.pdf | url-status = live }}</ref> Novartis removed it from all of the non-US markets and made it available only for compassionate use in those markets.<ref>{{cite web | title=Novartis Withdraws Chronic Leukemia Drug Arzerra From Non-U.S. Markets | website=FDANews | date=30 January 2018 | url=https://www.fdanews.com/articles/185419-novartis-withdraws-chronic-leukemia-drug-arzerra-from-non-us-markets | access-date=21 August 2020 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828194420/https://www.fdanews.com/articles/185419-novartis-withdraws-chronic-leukemia-drug-arzerra-from-non-us-markets | url-status=live }}</ref><ref>{{cite web | title=Novartis to transition use of Arzerra to compassionate use outside US | website=EPM Magazine | date=22 January 2018 | url=https://www.epmmagazine.com/api/content/3f6cee40-ff5a-11e7-8541-121bebc5777e/ | access-date=21 August 2020 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828194421/https://www.epmmagazine.com/pharma-manufacturing-news/novartis-to-transition-use-of-arzerra-to-compassionate-use-o/ | url-status=live }}</ref>

Ofatumumab (Kesimpta) was approved for the treatment of relapsing forms of multiple sclerosis in adults in the United States in August 2020.<ref name="Novartis PR">{{cite press release |title=FDA approves Novartis Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis |url=https://www.novartis.com/news/media-releases/fda-approves-novartis-kesimpta-ofatumumab-first-and-only-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis |access-date=21 August 2020 |date=20 August 2020 |publisher=Novartis |archive-date=24 September 2020 |archive-url=https://web.archive.org/web/20200924215304/https://www.novartis.com/news/media-releases/fda-approves-novartis-kesimpta-ofatumumab-first-and-only-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis |url-status=live }}</ref><ref>{{cite web | url=https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125326Orig1s070ltr.pdf | title=Ofatumumab (Kesimpta) FDA approval letter | access-date=22 August 2020 | archive-date=12 April 2021 | archive-url=https://web.archive.org/web/20210412094643/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125326Orig1s070ltr.pdf | url-status=live }}</ref> EU approval was subsequently received in March 2021.<ref name="Kesimpta EPAR" />

== Society and culture ==

=== Economics ===

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.<ref>{{cite press release | title=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 | publisher=Genmab A/S | via=GlobeNewswire | date=20 August 2020 | url=https://www.globenewswire.com/news-release/2020/08/20/2081670/0/en/Genmab-Announces-Plan-to-Transition-Arzerra-ofatumumab-to-an-Oncology-Access-Program-for-Chronic-Lymphocytic-Leukemia-Patients-in-the-U-S.html | access-date=16 April 2021 | archive-date=16 April 2021 | archive-url=https://web.archive.org/web/20210416192302/https://www.globenewswire.com/news-release/2020/08/20/2081670/0/en/Genmab-Announces-Plan-to-Transition-Arzerra-ofatumumab-to-an-Oncology-Access-Program-for-Chronic-Lymphocytic-Leukemia-Patients-in-the-U-S.html | url-status=live }}</ref>

== Further reading ==

{{refbegin}}

* {{cite journal | vauthors = Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T | title = 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 | journal = Blood | volume = 111 | issue = 3 | pages = 1094–1100 | date = February 2008 | pmid = 18003886 | doi = 10.1182/blood-2007-09-111781 | s2cid = 22333805 | doi-access = }}

* {{cite journal | vauthors = Zhang B | title = Ofatumumab | journal = mAbs | volume = 1 | issue = 4 | pages = 326–331 | date = July 2009 | pmid = 20068404 | pmc = 2726602 | doi = 10.4161/mabs.1.4.8895 | doi-access = free }}

{{refend}}

== External links ==

* {{ClinicalTrialsGov|NCT01848145|Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia}}

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