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Benralizumab

Generic Name
Benralizumab
Brand Names
Fasenra
Drug Type
Biotech
CAS Number
1044511-01-4
Unique Ingredient Identifier
71492GE1FX

Overview

Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin 5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Besides, it is an afucosylated IgG which gives it high affinity for the FcγRIIIα receptor in natural killer cells, macrophages and neutrophils. Benralizumab, FDA approved on November 14, 2017, was developed by MedImmune, the AstraZeneca's global biologic research and development arm.

Background

Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin 5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Besides, it is an afucosylated IgG which gives it high affinity for the FcγRIIIα receptor in natural killer cells, macrophages and neutrophils. Benralizumab, FDA approved on November 14, 2017, was developed by MedImmune, the AstraZeneca's global biologic research and development arm.

Indication

Benralizumab is indicated as a maintenance treatment of patients 12 years or older with severe asthma and an eosinophilic phenotype. The pathology of severe asthma with eosinophilic phenotype is also denotated as TH2-high phenotype. The patients with this phenotype are characterized by the expression of IL-5 and IL-13, airway hyperresponsiveness, responsiveness to inhaled corticosteroids, high serum IgE and eosinophilia in blood and airway. In the TH2-high phenotype, IL-5 presents a central role as it is responsible for eosinophil differentiation, survival, activation and migration to the lungs.

Associated Conditions

  • Severe Eosinophilic Asthma

FDA Approved Products

FASENRA
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:SUBCUTANEOUS
Strength:30 mg in 1 mL
Approved: 2021/02/23
NDC:0310-1830
FASENRA
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:SUBCUTANEOUS
Strength:30 mg in 1 mL
Approved: 2021/02/23
NDC:0310-1730

Singapore Approved Products

FASENRA SOLUTION FOR INJECTION 30MG/ML (PRE-FILLED SYRINGE)
Manufacturer:AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) (DP intermediate), Catalent Indiana, LLC, AstraZeneca AB
Form:INJECTION, SOLUTION
Strength:30 mg/ml
Online:Yes
Approved: 2019/05/09
Approval:SIN15683P
FASENRA SOLUTION FOR INJECTION 30MG/ML (AUTOINJECTOR PEN)
Manufacturer:Catalent Indiana, LLC, AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) (DP intermediate), AstraZeneca AB
Form:INJECTION, SOLUTION
Strength:30 mg / ml
Online:Yes
Approved: 2020/11/18
Approval:SIN16043P

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