Janssen Biotech is looking to expand the usage of its prescription drug Stelara, as it has asked the U.S. Food and Drug Administration (FDA) to test the drug on adolescent patients with moderate to severe plaque psoriasis, which has so far been approved for adults.
The J&J’s company on Friday said that it has submitted the Supplemental Biologics License Application (sBLA) to the FDA to treat adolescents of 12 to 17 years of age skin disease that affects about 7.5 million Americans. It is estimated that about one-third of those people develop the immune-mediated disease before 20 years of age, which can range from mild to severe and disabling.
Stelara is 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.