Research & Development
Janssen Submits Application Seeking US FDA Approval of Stelara for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
8 October 2021 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business has submitted a supplemental Biologics License Application to the US Food and Drug Administration seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages five years and older with juvenile psoriatic arthritis, the company said.

The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases.

Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions.

With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population.

A decision from the US FDA is anticipated in late 2022.

Stelara is the first and only biologic targeting both cytokines interleukin -12 and IL-23, both of which play an important role in inflammation associated with immune-mediated diseases like PsA.

Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has received approval for four additional indications: children (ages six and older) with moderate to severe plaque psoriasis, adults with active PsA, adults with moderately to severely active Crohn's disease and adults with moderately to severely active ulcerative colitis.

Juvenile arthritis occurs in an estimated 20 to 45 children per 100,000 children in the US, with approximately 5 % of those children having jPsA.

jPsA is characterized by both joint inflammation and psoriatic skin lesions that resemble adult PsA. PsA can be a challenging disease to treat especially in younger populations, reinforcing the need for additional treatment options.

Stelara (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients (18 years or older) with active PsA, used alone or in combination with methotrexate; adult patients (18 years and older) with moderately to severely active Crohn's disease; adult patients (18 years and older) with moderately to severely active ulcerative colitis.
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