Chemistry:Benralizumab

From HandWiki

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.[1][2]

Two phase III clinical trials of benralizumab reported meeting their primary endpoints in 2016.[3][4] It was approved by the US Food and Drug Administration in November 2017 for the treatment of severe eosinophilic asthma.[5] It was granted designation as an orphan drug by the Food and Drug Administration for treatment of eosinophilic oesophagitis in August 2019.[6]

Common adverse effects include injection site reactions, which were reported in 2.2% of patients (vs. 1.9% for placebo) in clinical trials.[7]

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).[8][9]

References

  1. ↑ Statement on a Nonproprietary Name adopted by the USAN Council: Benralizumab
  2. ↑ "Asthma & COPD--IQPC's Second Conference". IDrugs 13 (9): 601–604. September 2010. PMID 20799138. 
  3. ↑ "AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies". 5 September 2016. https://seekingalpha.com/news/3206982-astrazenecas-benralizumab-reduces-asthma-exacerbations-up-to-51-percent-in-two-late-state. 
  4. ↑ "Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma". The New England Journal of Medicine 376 (25): 2448–2458. June 2017. doi:10.1056/NEJMoa1703501. PMID 28530840. 
  5. ↑ "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.
  6. ↑ "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.
  7. ↑ FDA Professional Drug Information
  8. ↑ University of Oxford (2024-01-22). The Use of Benralizumab, an Interleukin-5 Receptor-α Monoclonal Antibody as Treatment of Acute Exacerbations of Airways Disease (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04098718. Retrieved 29 November 2024. 
  9. ↑ "Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial" (in English). The Lancet. Respiratory Medicine 13 (1): 59–68. November 2024. doi:10.1016/S2213-2600(24)00299-6. PMID 39615502. 




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