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Arzerra (HuMax-CD20)
Arzerra works by binding to the CD20 protein on B cells, marking them for destruction by the immune system.
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.
At a glance
| Generic name | HuMax-CD20 |
|---|---|
| Sponsor | Glaxo Grp Ltd |
| Drug class | CD20-directed Cytolytic Antibody |
| Target | B-lymphocyte antigen CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | discontinued |
| First approval | 2009 |
| Annual revenue | 3198 |
Mechanism of action
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.
Approved indications
- Chronic lymphoid leukemia, disease
- Relapsing multiple sclerosis
- Secondary progressive multiple sclerosis
Common side effects
- Infusion reactions
- Neutropenia
- Leukopenia
- Asthenia
- Headache
- Herpes simplex
- Lower respiratory tract infection
- Arthralgia
- Upper abdominal pain
- Pneumonia
- Pyrexia
- Cough
Key clinical trials
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (PHASE3)
- Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis (PHASE4)
- ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS (PHASE4)
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab (PHASE3)
- A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (PHASE2)
- Characterizing the Use of Ofatumumab in a Real World Setting
- Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (PHASE3)
- 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
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arzerra CI brief — competitive landscape report
- Arzerra updates RSS · CI watch RSS
- Glaxo Grp Ltd portfolio CI