Janssen Submits BLA to FDA Seeking Approval of Guselkumab for Treatment of Severe Plaque Psoriasis (JNJ)

November 17, 2016 8:18 AM EST

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Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (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. Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling.1

"We are committed to translating scientific advances into innovative therapies for chronic immune-mediated diseases like plaque psoriasis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to working with the FDA during the agency's review of the application as we believe guselkumab addresses continued needs of patients living with moderate to severe plaque psoriasis."

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 3 studies, and the X-PLORE Phase 2 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.



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