Benralizumab

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

    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 2 3 4 5 6 7 8 "Fasenra EPAR". European Medicines Agency (EMA). Archived from the original on 18 October 2020. Retrieved 13 October 2020.
    2. 1 2 3 4 5 6 "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.
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