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Belimumab

Generic Name
Belimumab
Brand Names
Benlysta
Drug Type
Biotech
CAS Number
356547-88-1
Unique Ingredient Identifier
73B0K5S26A

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

FDA Approved Products

BENLYSTA
Manufacturer:GlaxoSmithKline LLC
Route:SUBCUTANEOUS
Strength:200 mg in 1 mL
Approved: 2020/12/16
NDC:49401-088
BENLYSTA
Manufacturer:GlaxoSmithKline LLC
Route:INTRAVENOUS
Strength:400 mg in 5 mL
Approved: 2020/12/16
NDC:49401-102
BENLYSTA
Manufacturer:GlaxoSmithKline LLC
Route:INTRAVENOUS
Strength:120 mg in 1.5 mL
Approved: 2020/12/16
NDC:49401-101

Singapore Approved Products

Benlysta Powder for Solution for Infusion 400mg
Manufacturer:Hospira, Inc., GlaxoSmithKline Manufacturing S.P.A.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:400mg/vial
Online:Yes
Approved: 2012/08/21
Approval:SIN14212P
Benlysta Powder for Solution for Infusion 120mg
Manufacturer:Hospira, Inc., GlaxoSmithKline Manufacturing S.P.A.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:120mg/vial
Online:Yes
Approved: 2012/08/21
Approval:SIN14211P

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