Express Janssen IL-12/IL-23 inhibitor submits a new application to the FDA for the treatment of children with psoriatic arthritis

▎Editor of WuXi AppTec Content Team Recently, Janssen, a subsidiary of Johnson & Johnson, announced that it has submitted its IL-12/IL-23 inhibitor Stelara (ustekinumab) supplementary biological product license application to the US FDA ( sBLA), used to treat children with juvenile psoriatic arthritis (jPsA) over 5 years old
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The characteristics of juvenile psoriatic arthritis are similar to those of adult patients, with joint inflammation and psoriatic skin lesions
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Stelara is a humanized IL-12 and IL-23 antibody.
IL-12 and IL-23 are important cytokines that regulate the immune system and immune-mediated inflammatory diseases in the human body
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Stelara is the first biological product that targets both IL-12 and IL-23
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The drug has been approved in the United States for the treatment of: 1) moderate/severe plaque psoriasis adults and children over 6 years old who are suitable for phototherapy or systemic therapy; 2) adult patients with active psoriatic arthritis (18 3) Adult patients with moderate/severe active Crohn’s disease (over 18 years old); 4) Adult patients with moderate/severe active ulcerative colitis (over 18 years old)
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This application was supported by nine trials for adults with active psoriatic arthritis, adults and children with moderate to severe plaque psoriasis
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A total of 3997 patients were enrolled in all trials
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Dr.
Alyssa Johnsen, Vice President of Rheumatology, Janssen, said: “Children with juvenile psoriatic arthritis and their families urgently need a wide range of treatment options
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We are excited to work with the FDA to evaluate this potential treatment option to help meet the needs of children with psoriatic arthritis
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"Reference: [1] Janssen Submits Application Seeking US FDA Approval of Stelara® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis.
Retrieved October 10, 2021, from https:// releases/janssen-submits-application-seeking-us-fda-approval-of-Stelara-ustekinumab-for-the-treatment-of-pediatric-patients-with-juvenile-psoriatic-arthritis-301396106.
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