The Janssen Pharmaceutical Companies, a US-based pharmaceutical company wholly-owned by Johnson & Johnson, announced on Friday that it has submitted a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) for the expanded approval of STELARA (ustekinumab) for the treatment of paediatric patients aged five years and older with juvenile. psoriatic arthritis.
The company has filed the sBLA based on the extrapolation of data from nine studies across both adult trials in active psoriatic arthritis and adult and paediatric studies in moderate to severe plaque psoriasis, which total around 3,997 patients assessed across these closely associated diseases.
The company is expecting a decision from the FDA in late 2022.
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