{"id":"humax-cd20","rwe":[{"pmid":"29999646","year":"2006","title":"Ofatumumab.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"28850252","year":"2017","title":"The use of ofatumumab in the treatment of B-cell malignancies.","finding":"","journal":"Future oncology (London, England)","studyType":"Clinical Study"},{"pmid":"25154027","year":"2014","title":"Pro-apoptotic effect of an anti-CD37 scFv-Fc fusion protein, in combination with the anti-CD20 antibody, ofatumumab, on tumour cells from B-cell malignancies.","finding":"","journal":"European journal of cancer (Oxford, England : 1990)","studyType":"Clinical Study"},{"pmid":"21896924","year":"2011","title":"Ofatumumab: a novel anti-CD20 monoclonal antibody for treatment of refractory chronic lymphocytic leukemia.","finding":"","journal":"The Annals of pharmacotherapy","studyType":"Clinical Study"},{"pmid":"20194866","year":"2010","title":"Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.","finding":"","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","studyType":"Clinical Study"}],"tags":[{"label":"CD20-directed Cytolytic Antibody","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"B-lymphocyte antigen CD20","category":"target"},{"label":"MS4A1","category":"gene"},{"label":"L01FA02","category":"atc"},{"label":"Subcutaneous","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Chronic lymphoid leukemia, disease","category":"indication"},{"label":"Relapsing multiple sclerosis","category":"indication"},{"label":"Secondary progressive multiple sclerosis","category":"indication"},{"label":"Glaxo Grp Ltd","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":470.523,"date":"","count":329,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 329 times (LLR=471)"},{"llr":264.273,"date":"","count":206,"signal":"Chills","source":"DrugCentral FAERS","actionTaken":"Reported 206 times (LLR=264)"},{"llr":255.334,"date":"","count":152,"signal":"Influenza like illness","source":"DrugCentral FAERS","actionTaken":"Reported 152 times (LLR=255)"},{"llr":245.258,"date":"","count":96,"signal":"Aspergillus infection","source":"DrugCentral FAERS","actionTaken":"Reported 96 times (LLR=245)"},{"llr":240.868,"date":"","count":383,"signal":"Pyrexia","source":"DrugCentral FAERS","actionTaken":"Reported 383 times (LLR=241)"},{"llr":196.219,"date":"","count":86,"signal":"Cytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=196)"},{"llr":186.584,"date":"","count":105,"signal":"Multiple sclerosis relapse","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=187)"},{"llr":180.272,"date":"","count":218,"signal":"Neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 218 times (LLR=180)"},{"llr":157.615,"date":"","count":83,"signal":"Accidental exposure to product","source":"DrugCentral FAERS","actionTaken":"Reported 83 times (LLR=158)"},{"llr":132.897,"date":"","count":300,"signal":"Pneumonia","source":"DrugCentral FAERS","actionTaken":"Reported 300 times (LLR=133)"},{"llr":113.547,"date":"","count":62,"signal":"Neutropenic sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 62 times (LLR=114)"},{"llr":110.479,"date":"","count":128,"signal":"COVID-19","source":"DrugCentral FAERS","actionTaken":"Reported 128 times (LLR=110)"},{"llr":108.203,"date":"","count":169,"signal":"Infection","source":"DrugCentral FAERS","actionTaken":"Reported 169 times (LLR=108)"},{"llr":107.104,"date":"","count":100,"signal":"Haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=107)"},{"llr":92.771,"date":"","count":33,"signal":"Incorrect dose administered by device","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=93)"}],"commonSideEffects":[{"effect":"Infusion reactions","drugRate":"67%","severity":"serious"},{"effect":"Neutropenia","drugRate":"26.2%","severity":"serious"},{"effect":"Leukopenia","drugRate":"16.3%","severity":"serious"},{"effect":"Asthenia","drugRate":"8%","severity":"mild"},{"effect":"Headache","drugRate":"7%","severity":"mild"},{"effect":"Herpes simplex","drugRate":"6%","severity":"mild"},{"effect":"Lower respiratory tract infection","drugRate":"5.1%","severity":"mild"},{"effect":"Arthralgia","drugRate":"5%","severity":"mild"},{"effect":"Upper abdominal pain","drugRate":"5%","severity":"mild"},{"effect":"Pneumonia","drugRate":"≥10%","severity":"serious"},{"effect":"Pyrexia","drugRate":"≥10%","severity":"serious"},{"effect":"Cough","drugRate":"≥10%","severity":"serious"},{"effect":"Diarrhea","drugRate":"≥10%","severity":"serious"},{"effect":"Anemia","drugRate":"≥10%","severity":"serious"},{"effect":"Fatigue","drugRate":"≥10%","severity":"serious"},{"effect":"Dyspnea","drugRate":"≥10%","severity":"serious"},{"effect":"Rash","drugRate":"≥10%","severity":"serious"},{"effect":"Nausea","drugRate":"≥10%","severity":"serious"},{"effect":"Bronchitis","drugRate":"≥10%","severity":"serious"},{"effect":"Upper respiratory tract infections","drugRate":"≥10%","severity":"serious"},{"effect":"Lymphopenia","drugRate":"5.2%","severity":"mild"},{"effect":"Herpes virus infection","drugRate":"5%","severity":"mild"},{"effect":"Genital herpes","drugRate":"5%","severity":"mild"},{"effect":"Oral herpes","drugRate":"5%","severity":"mild"}],"specialPopulations":{"Pregnancy":"May cause fetal B-cell depletion. There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women. Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to KESIMPTA have not been studied in detail.","Geriatric use":"In patients with previously untreated CLL (Study 1), 68% (148/217) receiving ARZERRA plus chlorambucil were 65 years and older. Patients age 65 years and older experienced higher incidence of the following Grade or greater adverse reactions compared with patients younger than 65 years of age: neutropenia (30% versus 17%) and pneumonia (5% versus 1%). In patients 65 years and older, 29% experienced serious adverse events compared with 13% of patients younger than 65 years of age.","Paediatric use":"Safety and effectiveness of ARZERRA have not been established in children."}},"trials":[],"aliases":[],"company":"Glaxo Grp Ltd","patents":[],"pricing":[],"allNames":"arzerra","offLabel":[],"synonyms":["ofatumumab","arzerra","GSK1841157","HuMax-CD20","2F2"],"timeline":[{"date":"2009-10-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Glaxo Grp Ltd)"},{"date":"2010-04-19","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novartis Europharm Ltd)"},{"date":"2021-03-23","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Novartis Pharma K.K.)"}],"aiSummary":"Arzerra (HuMax-CD20) is a CD20-directed cytolytic antibody developed by Glaxo GSK Ltd. It targets B-lymphocyte antigen CD20, a protein found on the surface of B cells. Arzerra is used to treat chronic lymphocytic leukemia and certain types of multiple sclerosis. The drug is patented and commercially available. Key safety considerations include infusion reactions and cytopenias.","brandName":"Arzerra","ecosystem":[{"indication":"Chronic lymphoid leukemia, disease","otherDrugs":[{"name":"bendamustine","slug":"bendamustine","company":"Cephalon"},{"name":"chlorambucil","slug":"chlorambucil","company":"Aspen Global Inc"},{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"duvelisib","slug":"duvelisib","company":"Verastem Inc"}],"globalPrevalence":null},{"indication":"Relapsing multiple sclerosis","otherDrugs":[{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"}],"globalPrevalence":null},{"indication":"Secondary progressive multiple sclerosis","otherDrugs":[{"name":"siponimod","slug":"siponimod","company":"Novartis Pharms Corp"}],"globalPrevalence":null}],"mechanism":{"target":"B-lymphocyte antigen CD20","novelty":"Follow-on","targets":[{"gene":"MS4A1","source":"DrugCentral","target":"B-lymphocyte antigen CD20","protein":"B-lymphocyte antigen CD20"}],"moaClass":"CD20-directed Antibody Interactions","modality":"Monoclonal Antibody","drugClass":"CD20-directed Cytolytic Antibody","explanation":"The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, cell surface antigen present on pre-B and mature lymphocytes. Following cell surface binding to lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.","oneSentence":"Arzerra works by binding to the CD20 protein on B cells, marking them for destruction by the immune system.","technicalDetail":"Arzerra is a monoclonal antibody that binds to the CD20 antigen on the surface of B cells, triggering antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to the destruction of these cells."},"commercial":{"launchDate":"2009","revenueYear":2025,"_launchSource":"DrugCentral (FDA 2009-10-26, GLAXO GRP LTD)","annualRevenue":3198,"revenueSource":"Verified: Novartis 9M 2025","revenueCurrency":"USD","revenueConfidence":"verified","revenueExtractedAt":"2026-04-01T10:18:04.416664","revenueExtractedBy":"revenue-sec"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4951","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=HuMax-CD20","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HuMax-CD20","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T02:39:10.638123","biosimilars":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Novartis Pharmaceuticals Corporation","brandName":"ARZERRA","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Novartis Pharmaceuticals Corporation","brandName":"KESIMPTA","isOriginal":false,"marketingStatus":"BLA"}],"competitors":[{"drugName":"rituximab","drugSlug":"rituximab","fdaApproval":"1997-11-26","relationship":"same-class"},{"drugName":"obinutuzumab","drugSlug":"obinutuzumab","fdaApproval":"2013-11-01","relationship":"same-class"}],"genericName":"humax-cd20","indications":{"approved":[{"name":"Chronic lymphoid leukemia, disease","source":"DrugCentral","snomedId":92814006,"regulator":"FDA"},{"name":"Relapsing multiple sclerosis","source":"DrugCentral","snomedId":230372003,"regulator":"FDA","eligibility":"adults"},{"name":"Secondary progressive multiple sclerosis","source":"DrugCentral","snomedId":425500002,"regulator":"FDA","eligibility":"adults"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"rituximab","brandName":"rituximab","genericName":"rituximab","approvalYear":"1997","relationship":"same-class"},{"drugId":"obinutuzumab","brandName":"obinutuzumab","genericName":"obinutuzumab","approvalYear":"2013","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02792218","phase":"PHASE3","title":"Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":true,"startDate":"2016-09-20","conditions":["Relapsing Multiple Sclerosis"],"enrollment":930,"completionDate":"2020-07-20"},{"nctId":"NCT06444113","phase":"PHASE4","title":"Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-11-25","conditions":["Multiple Sclerosis"],"enrollment":24,"completionDate":"2026-10-29"},{"nctId":"NCT06733922","phase":"PHASE4","title":"ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-11-27","conditions":["Relapsing Remitting Multiple Sclerosis (RRMS)"],"enrollment":224,"completionDate":"2027-11-30"},{"nctId":"NCT06869785","phase":"PHASE3","title":"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-03-13","conditions":["Relapsing Multiple Sclerosis (RMS)"],"enrollment":196,"completionDate":"2030-03-23"},{"nctId":"NCT02135133","phase":"PHASE2","title":"A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2014-06","conditions":["Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma"],"enrollment":27,"completionDate":"2020-10-06"},{"nctId":"NCT05090033","phase":"","title":"Characterizing the Use of Ofatumumab in a Real World Setting","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-12-08","conditions":["Relapsing Multiple Sclerosis"],"enrollment":103,"completionDate":"2026-02-06"},{"nctId":"NCT03650114","phase":"PHASE3","title":"Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2018-12-28","conditions":["Relapsing Multiple Sclerosis"],"enrollment":1882,"completionDate":"2028-09-30"},{"nctId":"NCT06551519","phase":"","title":"A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-10-28","conditions":["Multiple Sclerosis"],"enrollment":700,"completionDate":"2028-11-29"},{"nctId":"NCT05344469","phase":"","title":"A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-05-10","conditions":["Relapsing Multiple Sclerosis"],"enrollment":800,"completionDate":"2029-05-30"},{"nctId":"NCT06345157","phase":"","title":"ITAKOS - 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