The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.
Developed by Janssen, Tremfya is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23, the first approved selective IL-23 inhibitor.
The sBLA for Tremfya is based on results from the Phase 3 DISCOVER-1 and DISCOVER-2 studies, which met their primary endpoints. The DISCOVER program comprises the first-ever Phase 3 studies evaluating a human monoclonal antibody against the p19 subunit of IL-23 for active PsA, and the results have been submitted for presentation at an upcoming medical meeting.
Additionally, there were several secondary endpoints were reached, including ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage using the van der Heide-Sharp score (vdH-S) as a key secondary endpoint.