FDA to Review Investigational Plaque Psoriasis Treatment

The submission is based on data from 4 clinical studies
The submission is based on data from 4 clinical studies

Janssen have announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA), seeking approval of guselkumab for the treatment of adults with moderate to severe plaque psoriasis.

Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets interleukin (IL)-23, a protein which has been shown to play a key role in the development of immune-mediated inflammatory diseases. 

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The submission is based on data from 4 studies; VOYAGE 1, VOYAGE 2 and NAVIGATE (Phase 3 studies) and X-PLORE (a Phase 3 study), which evaluated the efficacy and safety of guselkumab administered by subcutaneous injection in adults with moderate to severe plaque psoriasis.  Results from the Phase 2 X-PLORE study were published in the New England Journal of Medicine.

Positive results in a trial evaluating guselkumab in the treatment of psoriatic arthritis were presented at the 2016 ACR/ARHP annual meeting.

For more information visit Janssen.com.

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