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]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Interleukin 17 receptor A |
| Clinical data | |
| Trade names | Siliq, Kyntheum, Lumicef |
| Other names | KHK4827, AMG 827 |
| License data |
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| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6372H9840N1712O1988S52 |
| Molar mass | 143905.93 g·mol−1 |
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In February 2017, it received US FDA approval to treat moderate to severe plaque psoriasis in people who have not improved with other treatments.[6]
Mechanism of action
editBrodalumab 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
editBrodalumab 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 AstraZeneca reported encouraging results for the compound. The companies stated that the compound met the primary endpoint showing superior skin clearance in a Phase III trial when compared to ustekinumab 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, where Kyowa Hakko Kirin has rights to brodalumab and continued as KHK4827.
In September 2015, AstraZeneca announced a partnership with Valeant 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 to LEO Pharma.[12]
In January 2016, a biologics license application (BLA) was submitted to the US FDA.[13] Approval followed in February 2017.[6]
References
edit- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Regulatory Decision Summary for Siliq". 23 October 2014. Archived from the original on 7 June 2022. Retrieved 10 June 2022.
- ^ 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 1 February 2016. Retrieved 8 September 2011.
- ^ 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 3 December 2014. Retrieved 27 November 2014.
- ^ "Amgen to terminate participation in co-development and commercialization of brodaluma" (Press release). Amgen. Archived from the original on 26 May 2015. Retrieved 26 May 2015.
- ^ "AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab" (Press release). AstraZeneca. Archived from the original on 4 October 2021. Retrieved 10 June 2022.
- ^ "AstraZeneca enters licensing agreements with LEO Pharma in skin diseases" (Press release). AstraZeneca. Archived from the original on 3 October 2021. Retrieved 16 November 2016.
- ^ 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.
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