Benralizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD125
Clinical data
Pronunciationben" ra liz' ue mab
Trade namesFasenra
AHFS/Drugs.comMonograph
MedlinePlusa618002
License data
Pregnancy
category
  • AU: B1
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6492H10060N1724O2028S42
Molar mass146056.45 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

  1. ^ "Search Page - Drug and Health Product Register". 23 October 2014.
  2. ^ "Fasenra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 October 2020.
  3. ^ Statement on a Nonproprietary Name Archived 2016-08-15 at the Wayback Machine adopted by the USAN Council: Benralizumab
  4. ^ Catley MC (September 2010). "Asthma & COPD--IQPC's Second Conference". IDrugs. 13 (9): 601–4. PMID 20799138.
  5. ^ AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies. Sept 2016
  6. ^ 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.
  7. ^ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma". AstraZeneca. 2017-11-14.
  8. ^ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". www.astrazeneca.com. Retrieved 2019-10-29.
  9. ^ FDA Professional Drug Information

External links


Monoclonal antibodies for the immune system
Interleukin receptor modulators
AstraZeneca
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