Benralizumab

From WikiProjectMed
Jump to navigation Jump to search
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]

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). 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. ↑ "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.
  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. Archived from the original on 2018-11-07. Retrieved 2021-03-04.
  8. ↑ "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

External sites:
Identifiers:
Stub icon

This monoclonal antibody–related article is a stub. You can help MDWiki by expanding it.

Stub icon

This drug article relating to the respiratory system is a stub. You can help MDWiki by expanding it.

Retrieved from "https://mdwiki.org/w/index.php?title=Benralizumab&oldid=1375973"