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Last updated: 25 Aug 2015

Ofatumumab

Summary
Trade name: 
Arzerra
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
Class: 
Immunosuppressor
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Target: 
B cells
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
CD20
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Status for MS: 
Phase I/II trial is ongoing
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
Phase II trial is ongoing
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Administration: 
Intravenous
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
Subcutaneous
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Commercial: 
Marketed and developed by Genmab together with GlaxoSmithKline (2013)
(15)
Ofatumumab
Genmab, 2013
Accessed on 20 Sep 2013 from http://www.genmab.com/product-pipeline/products-in-development/ofatumumab.
Clinical trial conducted by GlaxoSmithKline
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Plans for a Phase III trial for testing the subcutaneous formulation in RRMS, beginning in 2015, have been announced by Genmab after a decision was made by its partner GlaxoSmithKline (30 May 2014)
(19)
Genmab Announces Ofatumumab Development Plans in RRMS and NMO
Genmab, 30 May 2014
Accessed on 5 Jun 2014 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=851521.
Plans for filing an Investigational New Drug Application for a pivotal study of the subcutaneous formulation in neuromyelitis optica have been announced by Genmab after a decision was made by its partner GlaxoSmithKline (30 May 2014)
(19)
Genmab Announces Ofatumumab Development Plans in RRMS and NMO
Genmab, 30 May 2014
Accessed on 5 Jun 2014 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=851521.
All remaining rights for development as a treatment for MS and other autoimmune conditions have been acquired by Novartis from GlaxoSmithKline (21 August 2015); Novartis had obtained the rights for oncology indications previously
(20)
Novartis acquires all remaining rights to GSK's Ofatumumab to develop treatments for MS and other autoimmune indications
Novartis, 21 Aug 2015
Accessed on 25 Aug 2015 from https://www.novartis.com/news/media-releases/novartis-acquires-all-remaining-rights-gsks-ofatumumab-develop-treatments-ms-and.
Names
Name: 
Ofatumumab
Trade name: 
Arzerra
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
Synonyms: 
Arzerra
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
GSK 1841157
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
GSK1841157
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
HuMax-CD20
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Ofatumumab
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-M95KG522R0
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Systematic name: 
Immunoglobulin G1, anti-(human CD20 (antigen))(human monoclonal HuMax- CD20 heavy chain), disulfide with human monoclonal HuMax-CD20 kappa- chain, dimer
(2)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class: 
Immunosuppressor
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Target: 
B cells
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
CD20
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Properties: 
Immunoglobulin G1 (IgG1) kappa human monoclonal antibody
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Molecular weight, 149 kD
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Pharmacokinetic data have been obtained in chronic lymphocytic leukemia patients
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
(6)
Food and Drug Administration briefing document for ofatumumab
Food and Drug Administration
Accessed on 15 Dec 2011 from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM163891.pdf.

Mechanisms/Effects

Human: 
Depletes B cells via antibody-dependent cell-mediated toxicity and complement-dependent cytotoxicity
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Antibody is directed against the small 7-mer loop of CD20 and binds in close proximity to the plasma membrane
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Binding target’s proximity to the cell membrane might explain why ofatumumab is more potent than rituximab and ocrelizumab at inducing complement
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Causes greater cell-mediated toxicity than rituximab or ocrelizumab (other anti-CD20 antibodies), perhaps because of its stronger binding to complement protein C1q
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Has a slower off-rate than rituximab, which also targets B cells and CD20
(5)
CD20-targeted therapy: a breakthrough in the treatment of non-Hodgkin's lymphoma.
van Meerten T, Hagenbeek A
Neth J Med. 2009 Jul-Aug; 67(7):251-9. PMID: 19687518. Abstract
Gradual B cell recovery is observed from week 20
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Regulatory and Commercial Status
Status for MS: 
Phase I/II trial is ongoing
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
Phase II trial is ongoing
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Highest status achieved (for any condition): 
Approved
(7)
FDA approval announcement for ofatumumab
Food and Drug Administration, 26 Oct 2009
Accessed on 26 Dec 2011 from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm188221.htm.
Other uses: 
Approved for chronic lymphocytic leukemia by the US Food and Drug Administration in 2009
(6)
Food and Drug Administration briefing document for ofatumumab
Food and Drug Administration
Accessed on 15 Dec 2011 from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM163891.pdf.
, by the European Medicine Agency in 2010
(12)
Arzerra
European Medicines Agency
Accessed on 17 Dec 2011 from http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/human_med_001300.jsp&murl=menus/medicines/medicines.jsp&jsenabled=true.
, and in Japan in 2013
(13)
Arzerra receives approval in Japan
Genmab, 25 Mar 2013
Accessed on 25 Mar 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=750534.
Currently in Phase III trials for relapsing or refractory follicular lymphoma and rheumatoid arthritis (2010)
(3)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Will be investigated for use in neuromyelitis optica (30 May 2014)
(19)
Genmab Announces Ofatumumab Development Plans in RRMS and NMO
Genmab, 30 May 2014
Accessed on 5 Jun 2014 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=851521.
Subcutaneous formulation is being investigated in a Phase III study for use in pemphigus vulgaris, a rare autoimmune disease of the skin (4 July 2013)
(14)
Genmab collaborator GSK starts new ofatumumab Phase III study in rare skin disorder
Genmab, 4 Jul 2013
Accessed on 16 Jul 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=775300.
Administration: 
Intravenous
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
Subcutaneous
(1)
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
GlaxoSmithKline, 16 Sep 2010
Accessed on 15 Dec 2011 from http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Negative effects: 
Anemia
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Anxiety
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Bronchitis
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Cough
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Diarrhea
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Dizziness
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Dyspnea (4)
Fatigue
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Fever
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Infections (most commonly upper respiratory tract infections)
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Infusion reactions
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Injection-related reactions
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Nerve pain
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Nausea
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Neutropenia
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Pneumonia
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Pyrexia
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
Rash
(4)
U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, et al.
Clin Cancer Res. 2010 Sep 1; 16(17):4331-8. Epub 2010 Jul 02. PMID: 20601446. Abstract
May lead to immunosuppression-related reactivation of the hepatitis B virus in previously-infected individuals; the US Food and Drug Administration requires this information to be displayed in a boxed warning (25 September 2013)
(17)
Boxed warning of HBV risk added to Rituxan, Arezerra
Medpage Today, 25 Sep 2013
Accessed on 29 Sep 2013 from http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/41864.
Commercial: 
Marketed and developed by Genmab together with GlaxoSmithKline (2013)
(15)
Ofatumumab
Genmab, 2013
Accessed on 20 Sep 2013 from http://www.genmab.com/product-pipeline/products-in-development/ofatumumab.
Clinical trial conducted by GlaxoSmithKline
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Plans for a Phase III trial for testing the subcutaneous formulation in RRMS, beginning in 2015, have been announced by Genmab after a decision was made by its partner GlaxoSmithKline (30 May 2014)
(19)
Genmab Announces Ofatumumab Development Plans in RRMS and NMO
Genmab, 30 May 2014
Accessed on 5 Jun 2014 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=851521.
Plans for filing an Investigational New Drug Application for a pivotal study of the subcutaneous formulation in neuromyelitis optica have been announced by Genmab after a decision was made by its partner GlaxoSmithKline (30 May 2014)
(19)
Genmab Announces Ofatumumab Development Plans in RRMS and NMO
Genmab, 30 May 2014
Accessed on 5 Jun 2014 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=851521.
All remaining rights for development as a treatment for MS and other autoimmune conditions have been acquired by Novartis from GlaxoSmithKline (21 August 2015); Novartis had obtained the rights for oncology indications previously
(20)
Novartis acquires all remaining rights to GSK's Ofatumumab to develop treatments for MS and other autoimmune indications
Novartis, 21 Aug 2015
Accessed on 25 Aug 2015 from https://www.novartis.com/news/media-releases/novartis-acquires-all-remaining-rights-gsks-ofatumumab-develop-treatments-ms-and.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
Ofatumumab Subcutaneous Administration in Subjects With Relapsiing-Remitting Multiple Sclerosis (MIRROR) (press release, 2013; meeting report, 2014)
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Phase: 
Phase II trial
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
Study Design: 
Company-funded, randomized, double-blind, parallel-group, placebo-controlled, multinational study to evaluate whether subcutaneous ofatumumab (3 mg, 30 mg, or 60 mg given every 12 weeks; 60 mg every 4 weeks; or placebo followed by 3 mg at week 12) reduces the number of new gadolinium-enhancing brain lesions over 12 weeks (primary endpoint)
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Disease Stage: 
RRMS
(11)
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
Clinicaltrials.gov, 2 Feb 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01457924.
Enrollment/Number of Patients: 
231
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Duration: 
24 weeks of treatment and at least 24 weeks of followup
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
Status/Outcome: 
All doses were associated with an estimated 65% reduction in the cumulative number of new lesions (based on analysis of data from weeks 0 to 12); all cumulative doses of at least 30 mg were associated with an estimated ≥90% reduction (based on data from weeks 4 to 12)
(16)
Genmab announces positive top-line Phase II results of ofatumumab in multiple sclerosis
Genmab, 10 Oct 2013
Accessed on 15 Oct 2013 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=796281.
; reduction of B cell concentration to 32 to 64 cells per microliter led to a reduction in disease activity (as assessed by the appearance of new lesions in the brain), such that the annualized rate of new brain lesions per year was <1 versus 16 without treatment
(18)
Study Suggests Targeting B Cells May Help with MS
American Academy of Neurology, 24 Apr 2014
Accessed on 5 May 2014 from https://www.aan.com/PressRoom/Home/PressRelease/1274.
Trial name: 
Ofatumumab Dose-finding in RRMS Patients, part A (interim data reported September 2010)
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
(10)
Genmab announces details of planned ofatumumab Phase II study in multiple sclerosis
Genmab, 13 Dec 2007
Accessed on 16 Dec 2011 from http://files.shareholder.com/downloads/AMDA-KPIBN/1749922934x0x538671/ebd956b9-b18b-4cd6-98e1-23b166dcbd79/538671.pdf.
Phase: 
Phase I/ II trial
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
Study Design: 
Company-funded, randomized, parallel-group, multi-center, multi-national placebo-controlled study evaluating effect of three doses (100 mg, 300 mg, and 700 mg) of ofatumumab on lesion number (primary endpoint)
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
(10)
Genmab announces details of planned ofatumumab Phase II study in multiple sclerosis
Genmab, 13 Dec 2007
Accessed on 16 Dec 2011 from http://files.shareholder.com/downloads/AMDA-KPIBN/1749922934x0x538671/ebd956b9-b18b-4cd6-98e1-23b166dcbd79/538671.pdf.
Disease Stage: 
RRMS
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
(10)
Genmab announces details of planned ofatumumab Phase II study in multiple sclerosis
Genmab, 13 Dec 2007
Accessed on 16 Dec 2011 from http://files.shareholder.com/downloads/AMDA-KPIBN/1749922934x0x538671/ebd956b9-b18b-4cd6-98e1-23b166dcbd79/538671.pdf.
Enrollment/Number of Patients: 
38 patients in part A; 288 patients expected in part B
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
(10)
Genmab announces details of planned ofatumumab Phase II study in multiple sclerosis
Genmab, 13 Dec 2007
Accessed on 16 Dec 2011 from http://files.shareholder.com/downloads/AMDA-KPIBN/1749922934x0x538671/ebd956b9-b18b-4cd6-98e1-23b166dcbd79/538671.pdf.
Duration: 
24 weeks part A; 48 weeks part B
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
(10)
Genmab announces details of planned ofatumumab Phase II study in multiple sclerosis
Genmab, 13 Dec 2007
Accessed on 16 Dec 2011 from http://files.shareholder.com/downloads/AMDA-KPIBN/1749922934x0x538671/ebd956b9-b18b-4cd6-98e1-23b166dcbd79/538671.pdf.
Status/Outcome: 
The drug was associated with reduction in gadolinium-enhancing lesions and raised no dose-related or other safety concerns in patients followed for 48 weeks (Part A)
(9)
Genmab announces results of ofatumumab Phase II study in multiple sclerosis
Genmab, 10 Sep 2010
Accessed on 16 Dec 2011 from http://ir.genmab.com/releasedetail.cfm?ReleaseID=639964.
; part B data expected in September, 2012
(8)
Ofatumumab Dose-finding in RRMS Patients
ClinicalTrials.gov, 20 May 2010
Accessed on 18 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00640328.
Head-to-Head Trials: 
Other Trials: 
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

Note: Compound name must be entered under "Substance Identification" and then "Names and Synonyms" selected to view synonyms.

FDA approval announcement for ofatumumab
Food and Drug Administration, 26 Oct 2009
Accessed on 26 Dec 2011 from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm188221.htm.
Arzerra
European Medicines Agency
Accessed on 17 Dec 2011 from http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/human_med_001300.jsp&murl=menus/medicines/medicines.jsp&jsenabled=true.
Ofatumumab
Genmab, 2013
Accessed on 20 Sep 2013 from http://www.genmab.com/product-pipeline/products-in-development/ofatumumab.
DOI: 
doi/10.7493/msdf.10.574.1