Janssen submits supplemental BLA for Stelara for adolescents with psoriasis

Janssen Biotech has announced it has submitted a supplemental biologics license application to the FDA for approval of Stelara for treating adolescents aged 12 to 17 years with moderate-to-severe plaque psoriasis.

Stelara (ustekinumab) is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines and has been approved for treating adults with moderate-to severe-plaque psoriasis in the US. Since 2009, according to a press release.

Approximately one-third of the estimated 7.5 million Americans with psoriasis develop the disease before 20 years of age, according to the release.

“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 psoriasis,” Newman Yeilding, MD, head of immunology development, Janssen Research & Development, LLC, stated in the release.

Data from the phase 3 CADMUS registration study, which measured efficacy and safety of ustekinumab in treating adolescents with moderate-to-severe plaque psoriasis were used to support the application. The efficacy and safety profile of ustekinumab in the trial was consistent with the profile of adults receiving ustekinumab, according to the release.

Reference: www.janssen.com