Overview
Belimumab is a fully human recombinant IgG1λ monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor. BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE). By binding to BLyS and blocking its interaction with B cell receptors, belimumab inhibits the survival of B cells. It is produced by recombinant DNA technology in a murine cell (NS0) expression system. Belimumab was first approved by the FDA on March 9, 2011, making it the newest drug to be approved for the treatment of SLE in more than 50 years. It is currently used to treat SLE and lupus nephritis.
Background
Belimumab is a fully human recombinant IgG1λ monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor. BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE). By binding to BLyS and blocking its interaction with B cell receptors, belimumab inhibits the survival of B cells. It is produced by recombinant DNA technology in a murine cell (NS0) expression system. Belimumab was first approved by the FDA on March 9, 2011, making it the newest drug to be approved for the treatment of SLE in more than 50 years. It is currently used to treat SLE and lupus nephritis.
Indication
In the US, belimumab is indicated to treat active systemic lupus erythematosus (SLE) and active lupus nephritis in patients aged five years and older who are receiving standard therapy. In Europe, belimumab is also used to treat SLE and lupus nephritis but only in adults. The efficacy of belimumab has not been evaluated in patients with severe active central nervous system lupus. Use of belimumab is not recommended in this situation.
Associated Conditions
- Active Systemic Lupus Erythematosus
- Lupus Nephritis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/01/28 | Phase 2 | Completed | |||
2014/04/21 | Phase 3 | Completed | |||
2013/08/02 | N/A | Completed | |||
2013/07/10 | Phase 1 | Completed | |||
2013/05/21 | N/A | Completed | Human Genome Sciences Inc., a GSK Company | ||
2013/01/08 | Phase 2 | Withdrawn | |||
2012/11/20 | N/A | Completed | |||
2012/08/22 | Phase 2 | Completed | Hospital for Special Surgery, New York | ||
2012/07/25 | Phase 2 | Active, not recruiting | |||
2012/06/04 | Phase 2 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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