Janssen Biotech submits BLA to FDA for guselkumab as a treatment for moderate to severe plaque psoriasis.

Janssen Biotech, Inc. announced the submission of a Biologics License Application (BLA) to the FDA seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody that targets interleukin (IL)-23, a protein which has been shown to play a key role in the development of immune-mediated inflammatory diseases.

Data from four studies evaluating the efficacy and safety of guselkumab administered by subcutaneous injection in the treatment of adults living with moderate to severe plaque psoriasis served as the basis for the submission. These studies include VOYAGE 1, VOYAGE 2 and NAVIGATE Phase III studies, and the X-PLORE Phase II study, which appeared in The New England Journal of Medicine in July 2015. Results from the VOYAGE 1 study were recently presented at the European Academy of Dermatology and Venereology congress, and results from the VOYAGE 2 and NAVIGATE studies are planned for presentation at upcoming scientific congresses.