Janssen submits application seeking U.S. FDA approval of Stelara (ustekinumab) for the treatment of paediatric patients with juvenile psoriatic arthritis

Johnson & Johnson

8 October 2021 - Application utilises extrapolation-based strategy across existing breadth of Stelara data in patients living with this chronic inflammatory disease.

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license application to the U.S. FDA seeking expanded approval of Stelara (ustekinumab) to treat paediatric patients ages 5 years and older with juvenile psoriatic arthritis.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier