| 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 |
|
|
Pregnancy category |
|
|
Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6492H10060N1724O2028S42 |
| Molar mass | 146056.45 g·mol−1 |
 
(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. [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]
References
- ^ "Search Page - Drug and Health Product Register". 23 October 2014.
- ^ "Fasenra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 October 2020.
- ^ Statement on a Nonproprietary Name Archived 2016-08-15 at the Wayback Machine adopted by the USAN Council: Benralizumab
- ^ Catley MC (September 2010). "Asthma & COPD--IQPC's Second Conference". IDrugs. 13 (9): 601–4. PMID 20799138.
- ^ AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies. Sept 2016
- ^ 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.
- ^ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma". AstraZeneca. 2017-11-14.
- ^ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". www.astrazeneca.com. Retrieved 2019-10-29.
- ^ FDA Professional Drug Information
 | This monoclonal antibody–related article is a stub. You can help Wikipedia by expanding it. |
 | This drug article relating to the respiratory system is a stub. You can help Wikipedia by expanding it. |
| 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 |
|
|
Pregnancy category |
|
|
Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6492H10060N1724O2028S42 |
| Molar mass | 146056.45 g·mol−1 |
|
(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. [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]
References
- ^ "Search Page - Drug and Health Product Register". 23 October 2014.
- ^ "Fasenra EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 October 2020.
- ^ Statement on a Nonproprietary Name Archived 2016-08-15 at the Wayback Machine adopted by the USAN Council: Benralizumab
- ^ Catley MC (September 2010). "Asthma & COPD--IQPC's Second Conference". IDrugs. 13 (9): 601–4. PMID 20799138.
- ^ AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies. Sept 2016
- ^ 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.
- ^ "Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma". AstraZeneca. 2017-11-14.
- ^ "Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis". www.astrazeneca.com. Retrieved 2019-10-29.
- ^ FDA Professional Drug Information
|
| This monoclonal antibody–related article is a stub. You can help Wikipedia by expanding it. |
|
| This drug article relating to the respiratory system is a stub. You can help Wikipedia by expanding it. |