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Fasenra (BENRALIZUMAB)
Fasenra works by binding to the interleukin-5 receptor on eosinophils, triggering their destruction.
At a glance
| Generic name | BENRALIZUMAB |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC] |
| Target | Interleukin-5 receptor subunit alpha |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 1800 |
Mechanism of action
Benralizumab is humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5R) with dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC).Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Benralizumab, by binding to the IL-5R chain, reduces eosinophils through ADCC; however, the mechanism of benralizumab action in asthma has no
Approved indications
- Eosinophilic asthma
Common side effects
- Headache
- Pharyngitis
- Hypersensitivity reactions
- Pyrexia
- Injection site reactions
- Anaphylaxis
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma (PHASE3)
- Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (PHASE3)
- Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma (PHASE2)
- Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy (PHASE3)
- Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma (PHASE3)
- A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (PHASE3)
- This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
- Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment (PHASE3)
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:
- Fasenra CI brief — competitive landscape report
- Fasenra updates RSS · CI watch RSS
- AstraZeneca portfolio CI