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FDA expands Stelara indication to cover paediatric plaque psoriasis

Published on 31/07/20 at 10:36am

Janssen’s IL-12 and IL-23 inhibitor Stelara (ustekinumab) has had its approved indications expanded by the FDA to include the treatment of skin lesions or plaques associated with moderate to severe plaque psoriasis in patients between six and 11 years old, it has been revealed.

The US regulator reached its decision based on Phase 3 clinical data derived from 44 participants with moderate to severe plaque psoriasis, with all patients aware they were receiving Janssen’s therapy for the duration of the study.. The findings supported Stelara’s efficacy, with 77% of participants achieving clear or almost clear skin 12 weeks after receiving the initial two doses.

Furthermore, it was found that 84% of participants achieved a score of 75% improvement according to the Psoriasis Area and Severity Index (PASI), while 64% saw an improvement of 90%, meeting the study’s secondary endpoints.

"We are thrilled that the latest approval for Stelara will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases," explained Dr Lloyd Miller, Vice President, Immunodermatology Disease Area Leader at Janssen. “While Stelara is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options."

Matt Fellows

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