Benralizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD125 |
| Clinical data | |
| Pronunciation | ben" ra liz' ue mab |
| Trade names | Fasenra |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618002 |
| License data |
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| Pregnancy category |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6492H10060N1724O2028S42 |
| Molar mass | 146056.45 g·mol−1 |
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Benralizumab, sold under the brand name Fasenra, is a monoclonal antibody directed against the alpha chain of the interleukin-5 receptor (CD125). It was developed by MedImmune for the treatment of asthma.[3][4]
Two phase III clinical trials of benralizumab reported meeting their primary endpoints in 2016.[5][6] It was approved by the US Food and Drug Administration in November 2017 for the treatment of severe eosinophilic asthma.[7] It was granted designation as an orphan drug by the Food and Drug Administration for treatment of eosinophilic oesophagitis in August 2019.[8]
Common adverse effects include injection site reactions, which were reported in 2.2% of patients (vs. 1.9% for placebo) in clinical trials.[9]
References
[edit]- ^ "Regulatory Decision Summary for Fasenra". 23 October 2014.
- ^ "Fasenra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 October 2020.
- ^ Statement on a Nonproprietary Name Archived 15 August 2016 at the Wayback Machine adopted by the USAN Council: Benralizumab
- ^ Catley MC (September 2010). "Asthma & COPD--IQPC's Second Conference". IDrugs. 13 (9): 601–4. PMID 20799138.
- ^ House DW (5 September 2016). "AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies". Seeking Alpha. Retrieved 7 September 2024.
- ^ Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, et al. (June 2017). "Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma". The New England Journal of Medicine. 376 (25): 2448–2458. doi:10.1056/NEJMoa1703501. PMID 28530840.
{{cite journal}}: CS1 maint: overridden setting (link) - ^ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma" (Press release). AstraZeneca. 14 November 2017.
- ^ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". AstraZeneca (Press release). 28 August 2019. Retrieved 29 October 2019.
- ^ FDA Professional Drug Information
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