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Brodalumab

From Wikipedia, the free encyclopedia
Monoclonal antibody
"Siliq" redirects here. For the type of fruit, seeSilique.

Pharmaceutical compound
Brodalumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterleukin 17 receptor A
Clinical data
Trade namesSiliq, Kyntheum, Lumicef
Other namesKHK4827, AMG 827
License data
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6372H9840N1712O1988S52
Molar mass143905.93 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Brodalumab, sold under the brand nameSiliq in the US andKyntheum in the EU, is a humanmonoclonal antibody designed for the treatment of inflammatory diseases.[3][4][5]

In February 2017, it received USFDA approval to treat moderate to severeplaque psoriasis in people who have not improved with other treatments.[6]

Mechanism of action

[edit]

Brodalumab binds to theinterleukin-17 receptor and so preventsinterleukin 17 (IL-17) from activating the receptor. This mechanism is similar to that of another anti-psoriasis antibody,ixekizumab, which however binds to IL-17 itself.

History

[edit]

Brodalumab was developed byAmgen, Inc. as AMG 827.

In 2013, it was in two phase III clinical trials for the treatment of moderate to severe psoriasis.[7][8]

In November 2014, Amgen andAstraZeneca reported encouraging results for the compound. The companies stated that the compound met theprimary endpoint showing superior skin clearance in a Phase III trial when compared toustekinumab and a placebo.[9]

However, in May 2015, Amgen announced that it was ending its participation in co-development of the compound because of reports of patients having "events of suicidal ideation and behavior".[10] AstraZeneca will be solely responsible for any future development and marketing of brodalumab in all territories except for certain Asian territories such as Japan, whereKyowa Hakko Kirin has rights to brodalumab and continued as KHK4827.

In September 2015, AstraZeneca announced a partnership withValeant Pharmaceuticals in which Valeant took over exclusive rights to develop and commercialize brodalumab.[11] In July 2016, the rights to commercialize brodalumab in Europe were sold toLEO Pharma.[12]

In January 2016, abiologics license application (BLA) was submitted to the US FDA.[13] Approval followed in February 2017.[6]

References

[edit]
  1. ^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)".nctr-crs.fda.gov.FDA. Retrieved22 October 2023.
  2. ^"Regulatory Decision Summary for Siliq". 23 October 2014.Archived from the original on 7 June 2022. Retrieved10 June 2022.
  3. ^ab"Siliq- brodalumab injection". DailyMed. 12 June 2020.Archived from the original on 18 March 2021. Retrieved8 June 2022.
  4. ^ab"Kyntheum EPAR". European Medicines Agency. 17 September 2018.Archived from the original on 13 September 2021. Retrieved8 June 2022.
  5. ^"Statement On A Nonproprietary Name Adopted By The USAN Council: Brodalumab"(PDF).American Medical Association.Archived(PDF) from the original on 1 February 2016. Retrieved8 September 2011.
  6. ^ab"FDA approves new psoriasis drug" (Press release). U.S. Food and Drug Administration. 15 February 2017.Archived from the original on 11 December 2019. Retrieved18 February 2017.
  7. ^Clinical trial numberNCT01708590 for "Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)" atClinicalTrials.gov
  8. ^Clinical trial numberNCT01708629 for "Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)" atClinicalTrials.gov
  9. ^Philippidis A (26 November 2014)."Brodalumab's No Turkey in Phase III: Amgen and AstraZeneca".Genetic Engineering & Biotechnology News. Archived fromthe original on 3 December 2014. Retrieved27 November 2014.
  10. ^"Amgen to terminate participation in co-development and commercialization of brodaluma" (Press release).Amgen.Archived from the original on 26 May 2015. Retrieved26 May 2015.
  11. ^"AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab" (Press release). AstraZeneca.Archived from the original on 4 October 2021. Retrieved10 June 2022.
  12. ^"AstraZeneca enters licensing agreements with LEO Pharma in skin diseases" (Press release). AstraZeneca.Archived from the original on 3 October 2021. Retrieved16 November 2016.
  13. ^House DW (25 January 2016)."FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFA date November 16".Seeking Alpha.Archived from the original on 8 February 2017. Retrieved10 June 2022.
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