Brodalumab
Interleukin 17 receptor A | |
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| Trade names | Siliq, Kyntheum, Lumicef |
| Other names | KHK4827, AMG 827 |
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| Formula | C6372H9840N1712O1988S52 |
| Molar mass | 143905.93 g·mol−1 |
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Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human monoclonal antibody designed for the treatment of inflammatory diseases.[3][4][5]
In February 2017, it received US
Mechanism of action
Brodalumab binds to the interleukin-17 receptor and so prevents interleukin 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
Brodalumab was developed by Amgen, 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 and
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".
In September 2015, AstraZeneca announced a partnership with
In January 2016, a biologics license application (BLA) was submitted to the US FDA.[13] Approval followed in February 2017.[6]
References
- FDA. Retrieved 22 Oct 2023.
- ^ "Search Page - Drug and Health Product Register". 23 October 2014. Archived from the original on 2022-06-07. Retrieved 2022-06-10.
- ^ a b "Siliq- brodalumab injection". DailyMed. 12 June 2020. Archived from the original on 18 March 2021. Retrieved 8 June 2022.
- ^ a b "Kyntheum EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 13 September 2021. Retrieved 8 June 2022.
- ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Brodalumab" (PDF). American Medical Association. Archived (PDF) from the original on 2016-02-01. Retrieved 2011-09-08.
- ^ a b "FDA approves new psoriasis drug" (Press release). U.S. Food and Drug Administration. 15 February 2017. Archived from the original on 11 December 2019. Retrieved 18 February 2017.
- ^ Clinical trial number NCT01708590 for "Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)" at ClinicalTrials.gov
- ^ Clinical trial number NCT01708629 for "Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)" at ClinicalTrials.gov
- ^ Philippidis A (26 November 2014). "Brodalumab's No Turkey in Phase III: Amgen and AstraZeneca". Genetic Engineering & Biotechnology News. Archived from the original on 2014-12-03. Retrieved 2014-11-27.
- ^ "Amgen to terminate participation in co-development and commercialization of brodaluma" (Press release). Amgen. Archived from the original on 2015-05-26. Retrieved 2015-05-26.
- ^ "AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab" (Press release). AstraZeneca. Archived from the original on 2021-10-04. Retrieved 2022-06-10.
- ^ "AstraZeneca enters licensing agreements with LEO Pharma in skin diseases" (Press release). AstraZeneca. Archived from the original on 2021-10-03. Retrieved 2016-11-16.
- ^ 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. Retrieved 10 June 2022.
External links
- "Brodalumab". Drug Information Portal. U.S. National Library of Medicine.