FDA approves Stelara for treating adolescents with psoriasis

Janssen Biotech Inc. announced in a press release that the FDA has approved an expanded indication of Stelara for treating adolescents aged 12 years or older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

The FDA approval of Stelara (ustekinumab) for the indication is based on data from a phase 3 study of subcutaneous administration of ustekinumab in patients aged 12 years or older. At the week 12 primary endpoint, at least two-thirds of the patients receiving ustekinumab were responders after two doses at weeks 0 and 4, which was defined by achieving a Physician’s Global Assessment Score of 0 or 1 (cleared or minimal psoriasis), according to the release.

Stelara 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 U.S. since 2009, according to a press release.

Approximately one-third of the 7.5 million Americans with psoriasis develop the skin disease before age 20 years, and there have been limited treatment options for adolescents, Janssen reported.

Janssen submitted a supplemental biologics license application to the FDA in December 2016 for the approval of Stelara for treating adolescents aged 12 to 17 years with moderate-to-severe plaque psoriasis.

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