Janssen Submits sBLA to FDA for Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis in Children Aged 5 and Older

Recently, Janssen Pharmaceuticals, a Johnson & Johnson company, announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for its IL-12/IL-23 inhibitor Stelara (ustekinumab) for the treatment of pediatric patients aged 5 years and older with juvenile psoriatic arthritis (jPsA). The clinical features of juvenile psoriatic arthritis are similar to those in adult patients, characterized by joint inflammation and psoriatic skin lesions.

Stelara is a humanized IL-12 and IL-23 antibody. IL-12 and IL-23 are important cytokines in the human body that regulate the immune system and immune-mediated inflammatory diseases. Stelara is the first biologic to simultaneously target IL-12 and IL-23. The drug has been approved in the United States for the treatment of: 1) adult and pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years of age and older) with active psoriatic arthritis; 3) adult patients (18 years of age and older) with moderately to severely active Crohn's disease; 4) adult patients (18 years of age and older) with moderately to severely active ulcerative colitis.

This application is supported by 9 trials in adult patients with active psoriatic arthritis and adult and pediatric patients with moderate-to-severe plaque psoriasis. A total of 3,997 patients were enrolled across all trials.

References:

[1] Janssen Submits Application Seeking U.S. FDA Approval of Stelara® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis. Retrieved October 10, 2021, from https://www.prnewswire.com/news-releases/janssen-submits-application-seeking-us-fda-approval-of-Stelara-ustekinumab-for-the-treatment-of-pediatric-patients-with-juvenile-psoriatic-arthritis-301396106.html

(Original text abridged)

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