Stelara ustekinumab regulatory update

Johnson & Johnson's Janssen-Cilag International N.V. unit submitted a Type II variation application to EMA for Stelara ustekinumab to treat moderate to severe plaque psoriasis in patients ages 12-17 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The human mAb inhibiting IL-12 and IL-23 is approved in the EU for the indication in adults. Stelara is also approved in the EU as monotherapy or in combination with methotrexate to treat active psoriatic arthritis in adult patients when the response to DMARD therapy has been inadequate. ...