CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Tremfya (guselkumab) – Johnson & Johnson

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tremfya (guselkumab). The marketing authorisation holder is Janssen-Cilag International NV, a J&J company.  The CHMP adopted a new indication, as follows: Paediatric plaque psoriasis- Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.