Brodalumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Interleukin 17 receptor A |
| Clinical data | |
| Trade names | Siliq |
| ATC code | |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| ChemSpider |
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| KEGG | |
| Chemical and physical data | |
| Formula | C6372H9840N1712O1988S52 |
| Molar mass | 144.06 kg/mol |
  (what is this?) (verify) | |
Brodalumab (US trade name Siliq Europe Kyntheum ) is a human monoclonal antibody designed for the treatment of inflammatory diseases.[1][2]
In February 2017 it received US FDA approval to treat moderate to severe plaque psoriasis in people who have not improved with other treatments.[3] Use is linked to an increased risk of suicide.[3]
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.
In 2013 it was in two phase III clinical trials for the treatment of moderate to severe psoriasis.[4][5]
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.[6]
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".[7] 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.
In September 2015, AstraZeneca announced a partnership with Valeant Pharmaceuticals in which Valeant took over exclusive rights to develop and commercialize brodalumab.[8] In July 2016, the rights to commercialize brodalumab in Europe were sold to LEO Pharma.[9]
In January 2016, a biologics license application (BLA) was submitted to the US FDA.[10] Approval followed in February 2017.[3]
References
- ↑ "Statement On A Nonproprietary Name Adopted By The USAN Council: Brodalumab" (PDF). American Medical Association.
- ↑ EMA CHMP opinion on Kyntheum. May 2017
- 1 2 3 Commissioner, Office of the (15 February 2017). "Press Announcements - FDA approves new psoriasis drug". www.fda.gov. 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
- ↑ http://www.genengnews.com/gen-news-highlights/brodalumab-s-no-turkey-in-phase-iii-amgen-and-astrazeneca/81250645/
- ↑ "Amgen to terminate participation in co-development and commercialization of brodaluma". Amgen.
- ↑ http://www.astrazeneca.com/Media/Press-releases/Article/20150901--astrazeneca-and-valeant-pharmaceuticals-partnership
- ↑ https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca-enters-licensing-agreements-with-leo-pharma-in-skin-diseases-01072016.html
- ↑ FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFA date November 16Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis. Jan 2016