Janssen Biotech, Inc. has announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA®, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
"Adolescence is an important developmental period, and a diagnosis of moderate to severe plaque psoriasis can present physical and emotional challenges for girls and boys," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the FDA on this application with the hope that in the future, we may be able to offer STELARA® to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis."
The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety of STELARA® in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Results from the CADMUS study have been previously published in the Journal of the American Academy of Dermatology in May 2015. The efficacy and safety profile of STELARA® in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving STELARA®.