Benralizumab

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Benralizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD125
Names
Pronunciationben" ra liz' ue mab
Trade namesFasenra
Clinical data
Main usesEosinophilic asthma[1]
Side effectsHeadache, sore throat[1]
Pregnancy
category
  • AU: B1
  • US: N (Not classified yet)
Routes of
use
Subcutaneous
Typical dose30 mg[2]
External links
AHFS/Drugs.comMonograph
US NLMBenralizumab
MedlinePlusa618002
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)
  • US: ℞-only
  • EU: Rx-only [1]
Chemical and physical data
FormulaC6492H10060N1724O2028S42
Molar mass146056.45 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Benralizumab, sold under the brand name Fasenra, is a medication used to treat eosinophilic asthma.[1] It may be used in those not controlled with inhaled corticosteroids and a long-acting beta-agonist.[1] It is given by injection under the skin.[2]

Common side effects include headache and sore throat.[1] Other side effects may include anaphylaxis or hives.[2] Safety in pregnancy is unclear.[2] It is a monoclonal antibody that binds to interleukin-5 receptors (CD125) on eosinophils, resulting in their destruction.[1]

Benralizumab was approved for medical use in the United States in 2017 and Europe in 2018.[2][1] In the United Kingdom it costs the NHS about £2,000 per dose as of 2021.[3] This amount is about 5,200 USD in the United States.[4]

Medical uses

Dosage

It is give at a dose of 30 mg every 4 weeks for three doses, than every 8 weeks.[2]

History

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]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Fasenra EPAR". European Medicines Agency (EMA). Retrieved 13 October 2020.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 "DailyMed - FASENRA- benralizumab injection, solution". dailymed.nlm.nih.gov. Retrieved 9 January 2022.
  3. BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 284. ISBN 978-0857114105.
  4. "Fasenra Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 9 January 2022.
  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.

External links

External sites:
Identifiers: