Brodalumab

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"Siliq" redirects here. For the type of fruit, see Silique.
Brodalumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterleukin 17 receptor A
Clinical data
Trade namesSiliq, Kyntheum
Other namesKHK4827, AMG 827
License data
ATC code
Legal status
Legal status
  • US: ℞-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6372H9840N1712O1988S52
Molar mass143905.93 g·mol−1
 ☒NcheckY (what is this?)  

Brodalumab (trade name Siliq in the US and Kyntheum in Europe) 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]

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.[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 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.[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[]

  1. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Brodalumab" (PDF). American Medical Association.
  2. ^ "EMA CHMP opinion on Kyntheum. May 2017".
  3. ^ a b Office of the Commissioner (15 February 2017). "Press Announcements - FDA approves new psoriasis drug". www.fda.gov. Retrieved 18 February 2017.
  4. ^ 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
  5. ^ 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
  6. ^ 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.
  7. ^ "Amgen to terminate participation in co-development and commercialization of brodaluma". Amgen.
  8. ^ "AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab". www.astrazeneca.com.
  9. ^ "AstraZeneca enters licensing agreements with LEO Pharma in skin diseases". www.astrazeneca.com.
  10. ^ House DW (25 January 2016). "FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFA date November 16". Seeking Alpha.


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