Chemistry:Benralizumab

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Short description: Monoclonal antibody
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
  • US: N (Not classified yet)
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
 ☒N☑Y (what is this?)  (verify)

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. https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00337. 
  2. ↑ "Fasenra EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/fasenra. 
  3. ↑ Statement on a Nonproprietary Name adopted by the USAN Council: Benralizumab
  4. ↑ "Asthma & COPD--IQPC's Second Conference". IDrugs 13 (9): 601–4. September 2010. PMID 20799138. 
  5. ↑ AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies. Sept 2016
  6. ↑ "Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma". The New England Journal of Medicine 376 (25): 2448–2458. June 2017. doi:10.1056/NEJMoa1703501. PMID 28530840. 
  7. ↑ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma". AstraZeneca. 2017-11-14. https://www.astrazeneca-us.com/media/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-eosinophilic-asthma-11142017.html#!. 
  8. ↑ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis" (in en). https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-granted-us-orphan-drug-designation-for-eosinophilic-oesophagitis-28082019.html. 
  9. ↑ FDA Professional Drug Information




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