Posted by Michael Wonder on 18 Dec 2016
Janssen submits application seeking FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis
16 December 2016 - Janssen Biotech announced today the submission of a supplemental biologics license application to the U.S. 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.
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.
