Benralizumab

Benralizumab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD125
Clinical data
Pronunciation	ben" ra liz' ue mab
Trade names	Fasenra
AHFS/Drugs.com	Monograph
MedlinePlus	a618002
License data	US DailyMed: Benralizumab
Pregnancy category	AU: B1
Routes of administration	Subcutaneous
ATC code	R03DX10 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only / Schedule D[1] UK: POM (Prescription only) US: ℞-only EU: Rx-only[2]
Identifiers
CAS Number	1044511-01-4^N
DrugBank	DB12023^Y
ChemSpider	none
UNII	71492GE1FX
KEGG	D09874^N
Chemical and physical data
Formula	C6492H10060N1724O2028S42
Molar mass	146056.45 g·mol^−1
^NY (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. It is currently marketed by Astrazeneca.^[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]

Clinical Trials

In November 2024, the ABRA study found that a single dose of benralizumab could be more effective when injected at the point of exacerbation compared to currently used steroid tablets in patients at high risk of an asthma or chronic obstructive pulmonary disease (COPD).^[10][11]

References

1. "Regulatory Decision Summary for Fasenra". 23 October 2014. Archived from the original on 5 January 2023. Retrieved 29 November 2024.
2. "Fasenra EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 18 October 2020. Retrieved 13 October 2020.
3. Statement on a Nonproprietary Name Archived 15 August 2016 at the Wayback Machine adopted by the USAN Council: Benralizumab
4. Catley MC (September 2010). "Asthma & COPD--IQPC's Second Conference". IDrugs. 13 (9): 601–604. PMID 20799138.
5. House DW (5 September 2016). "AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies". Seeking Alpha. Archived from the original on 7 September 2024. Retrieved 7 September 2024.
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" (Press release). AstraZeneca. 14 November 2017. Archived from the original on 7 November 2018. Retrieved 15 November 2017.
8. "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". AstraZeneca (Press release). 28 August 2019. Archived from the original on 29 October 2019. Retrieved 29 October 2019.
9. FDA Professional Drug Information
10. University of Oxford (22 January 2024). The Use of Benralizumab, an Interleukin-5 Receptor-α Monoclonal Antibody as Treatment of Acute Exacerbations of Airways Disease (Report). clinicaltrials.gov. Archived from the original on 23 September 2024. Retrieved 29 November 2024.
11. Ramakrishnan S, Russell RE, Mahmood HR, Krassowska K, Melhorn J, Mwasuku C, et al. (November 2024). "Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial". The Lancet. Respiratory Medicine. 0 (0). doi:10.1016/S2213-2600(24)00299-6. PMID 39615502.