Benralizumab: Difference between revisions

{{Short description|Monoclonal antibody}}

{{Use dmy dates|date=August 2024}}

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| pronounce = ben" ra liz' ue mab

| tradename = Fasenra

| Drugs.com = {{drugs.com|monograph|benralizumab}}

| MedlinePlus = a618002

| DailyMedID = Benralizumab

| pregnancy_AU = B1

| pregnancy_category =

| routes_of_administration = [[Subcutaneous injection|Subcutaneous]]

| ATC_prefix = R03

| ATC_suffix = DX10

| legal_AU = S4

| legal_CA = Rx-only

| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00337 | title=Regulatory Decision Summary for Fasenra | date=23 October 2014 }}</ref>

| legal_UK = POM

| legal_US = Rx-only

| legal_EU = Rx-only

| legal_EU_comment = <ref name="Fasenra EPAR">{{cite web | title=Fasenra EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fasenra | access-date=13 October 2020}}</ref>

| legal_status =

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| CAS_number_Ref = {{cascite|changed|??}}

| CAS_number = 1044511-01-4

| PubChem =

| DrugBank = DB12023

| UNII_Ref = {{fdacite|correct|FDA}}

| KEGG = D09874

| ChemSpiderID = none

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| C=6492 | H=10060 | N=1724 | O=2028 | S=42

'''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]].<ref>[http://www.ama-assn.org/ama1/pub/upload/mm/365/benralizumab.pdf Statement on a Nonproprietary Name] {{Webarchive|url=https://web.archive.org/web/20160815201934/http://www.ama-assn.org/ama1/pub/upload/mm/365/benralizumab.pdf |date=15 August 2016 }} adopted by the [[USAN Council]]: Benralizumab</ref><ref>{{cite journal | vauthors = Catley MC | title = Asthma & COPD--IQPC's Second Conference | journal = IDrugs | volume = 13 | issue = 9 | pages = 601–4 | date = September 2010 | pmid = 20799138 }}</ref>

Two phase III clinical trials of benralizumab reported meeting their [[primary endpoint]]s in 2016.<ref>{{cite web | first=Douglas W. | last = House | title=AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies | website=Seeking Alpha | date=5 September 2016 | url=https://seekingalpha.com/news/3206982-astrazenecas-benralizumab-reduces-asthma-exacerbations-up-to-51-percent-in-two-late-state | access-date=7 September 2024}}</ref><ref>{{cite journal | vauthors = Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M | display-authors = 6 | title = Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma | journal = The New England Journal of Medicine | volume = 376 | issue = 25 | pages = 2448–2458 | date = June 2017 | pmid = 28530840 | doi = 10.1056/NEJMoa1703501 | doi-access = free }}</ref> It was approved by the US [[Food and Drug Administration]] in November 2017 for the treatment of severe [[eosinophilic asthma]].<ref>{{cite press release |url=https://www.astrazeneca-us.com/media/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-eosinophilic-asthma-11142017.html |title=Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma|publisher=AstraZeneca|date=14 November 2017}}</ref> It was granted designation as an [[orphan drug]] by the Food and Drug Administration for treatment of [[eosinophilic oesophagitis]] in August 2019.<ref>{{Cite press release |url=https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-granted-us-orphan-drug-designation-for-eosinophilic-oesophagitis-28082019.html|title=Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis|website=AstraZeneca|date=28 August 2019 |access-date=29 October 2019}}</ref>

Common adverse effects include [[injection site reaction]]s, which were reported in 2.2% of patients (vs. 1.9% for placebo) in clinical trials.<ref>{{Drugs.com|pro|fasenra}}</ref>

{{Reflist}}

{{Interleukin receptor modulators}}

{{AstraZeneca}}

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[[Category:Antiasthmatic drugs]]

[[Category:Anti-interleukin monoclonal antibodies]]

[[Category:Drugs developed by AstraZeneca]]

[[Category:Orphan drugs]]

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