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Johnson & Johnson Seeks FDA Approval of Tremfya in Children
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Johnson & Johnson Seeks FDA Approval of Tremfya in Children
Dec 2, 2024 6:20 AM

08:55 AM EST, 12/02/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Monday it submitted two supplemental biologics license applications to the US Food and Drug Administration for Tremfya to treat children 6 years and older with moderate-to-severe plaque psoriasis and children 5 years and older with active juvenile psoriatic arthritis.

The applications are supported by phase 3 trial data in pediatric plaque psoriasis patients and pharmacokinetic extrapolation data from adult studies, Johnson & Johnson ( JNJ ) said.

Tremfya, or guselkumab, is currently approved in the US to treat adults with moderate to severe plaque psoriasis or active psoriatic arthritis.

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