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
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

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]

Mechanism of action

Mechanism of benralizumab[5]

In terms of the mode of action we find that Benralizumab binds with the α-chain of IL-5R1, this impedes IL-5 from binding to its receptor. Due to the aforementioned inhibition, Benralizumab blocks the hetero-oligomerization of alpha/beta subunits of IL-5R, as a consequence signal transduction is stopped.[5]

History

Two phase III clinical trials of benralizumab reported meeting their primary endpoints in 2016.[6][7]

It was approved by the US Food and Drug Administration in November 2017 for the treatment of severe eosinophilic asthma.[8]

It was granted designation as an orphan drug by the Food and Drug Administration for treatment of eosinophilic oesophagitis in August 2019.[9]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Fasenra EPAR". European Medicines Agency (EMA). Archived from the original on 18 October 2020. 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. Archived from the original on 13 May 2021. 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. ↑ 5.0 5.1 Pelaia, Corrado; Vatrella, Alessandro; Bruni, Andrea; Terracciano, Rosa; Pelaia, Girolamo (21 March 2018). "Benralizumab in the treatment of severe asthma: design, development and potential place in therapy". Drug Design, Development and Therapy. 12: 619–628. doi:10.2147/DDDT.S155307. Archived from the original on 15 June 2022. Retrieved 25 June 2024.
  6. ↑ "AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies. Sept 2016". Archived from the original on 2016-10-11. Retrieved 2021-03-04.
  7. ↑ 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.
  8. ↑ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma". AstraZeneca. 2017-11-14. Archived from the original on 2018-11-07. Retrieved 2021-03-04.
  9. ↑ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". www.astrazeneca.com. Archived from the original on 2019-10-29. Retrieved 2019-10-29.

External links

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