Tremfya filed with FDA for psoriatic arthritis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking first-in-class approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA). Developed by Janssen, Tremfya is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23. It was approved in the U.S. in July 2017 for the treatment of adult patients with moderate to severe plaque psoriasis and has also been approved in Canada, the European Union, Japan and several other countries worldwide.

The Tremfya sBLA is based on results from the Phase III DISCOVER-1 and DISCOVER-2 studies, which met their primary endpoints of patients achieving an American College of Rheumatology 20 percent improvement (ACR20) response after 24 weeks of treatment. The safety profile observed for Tremfya in the DISCOVER studies was generally consistent with previous studies as well as the current Tremfya prescribing information. The DISCOVER program comprises the first-ever Phase III 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.

In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed, 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.

Comment: Tremfya is the first approved selective IL-23 inhibitor. Janssen also 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.