Brodalumab

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Brodalumab
Monoclonal antibody
Type Whole antibody
Source Human
Target Interleukin 17 receptor A
Clinical data
Trade names Siliq
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
KEGG
Chemical and physical data
Formula C6372H9840N1712O1988S52
Molar mass 144.06 kg/mol
 NYesY (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[edit]

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[edit]

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[edit]