Posted by Michael Wonder on 23 Oct 2019
Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis
23 October 2019 - If approved, guselkumab will be the first selective IL-23 p19 subunit inhibitor for people in the European Union with active psoriatic arthritis.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II variation application to the EMA seeking first-in-class approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis. If approved, this will be the second approved indication for guselkumab in the European Union.
This regulatory submission is based on data from the Phase 3 DISCOVER-1 and DISCOVER-2 studies.
