Janssen Submits TREMFYA Application to FDA for Psoriatic Arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (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. TREMFYA is the first approved selective IL-23 inhibitor. 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 3 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 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.

"We're excited about the DISCOVER data and the potential of TREMFYA as a treatment option given the unmet needs of patients living with psoriatic arthritis, a chronic lifelong disease," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "DISCOVER-1 and 2 are the ninth and tenth Phase 3 studies Janssen has completed in PsA, across our portfolio of medicines."

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.

"With this submission to the FDA, we hope to offer the first IL-23 p19 inhibitor to clinicians and their patients for active psoriatic arthritis," said Andrew Greenspan, M.D., Vice President, Immunology Medical Affairs, Janssen Scientific Affairs. "Psoriatic arthritis is a complex disease involving both the skin and the joints with a heterogeneous range of clinical manifestations, and it requires treatment options with different mechanisms of action."

Both DISCOVER trials were randomized, double-blind, multicenter Phase 3 studies designed to evaluate the efficacy and safety of TREMFYA administered by subcutaneous injection in patients with active PsA compared to placebo. DISCOVER-1 evaluated 381 participants, including those previously treated with anti-TNF therapy, and continued through 52 weeks. DISCOVER-2 included 739 biologic-naïve participants and is planned to continue through 100 weeks.

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.

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by joint inflammation, enthesitis, dactylitis and the skin manifestations of psoriasis. It is estimated that at least one million Americans are living with PsA, and up to 30 percent of patients living with psoriasis can develop PsA. The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.

Developed by Janssen, TREMFYA® is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23, and is approved in the U.S., Canada, the European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet [UV] light). IL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis and psoriatic arthritis. The TREMFYA development program includes: two Phase 3 programs evaluating TREMFYA in the treatment of active psoriatic arthritis, a Phase 2b/3 program in Crohn's disease, a Phase 2b/3 program in Ulcerative Colitis, and two Phase 2 programs – one exploring biologic combination therapy in Ulcerative Colitis and the other for the treatment of Hidradenitis Suppurativa.

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