Janssen submits application to U.S. FDA seeking approval of Stelera (ustekinumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis

Janssen

7 October 2019 - 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 (ages 6-11) patients with moderate to severe plaque psoriasis.

The application is based on results from the Phase 3 CADMUS Jr study, in which the primary endpoint of the proportion of patients achieving a Physician's Global Assessment score of cleared (0) or minimal (1) at week 12 was met.

Read Janssen press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier