Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Tremfya is a human monoclonal antibody with a novel mechanism of action that targets interleukin (IL)-23. The FDA’s approval was based on data from the clinical program that investigated over 2,000 patients across the Phase 3 VOYAGE 1, VOYAGE 2, and NAVIGATE studies.
Clinical data from VOYAGE 1 and VOYAGE 2 showed significant improvement in skin clearance at Week 16 in patients who received Tremfya compared to placebo with ≥70% of Tremfya-treated patients achieving PASI 90 and >80% of patients achieving cleared or almost cleared skin. Nearly 90% of Tremfya-treated patients who achieved PASI 90 at Week 28 showed maintained response through Week 48.
In addition, patients reported greater improvement with their scalp and plaque psoriasis symptoms such as itch, pain, stinging, burning, and skin tightness compared to placebo. When evaluated against Humira (adalimumab; AbbVie), superior efficacy in skin clearance (PASI 90) was seen with Tremfya at Weeks 16, 24, and 48.
In the NAVIGATE study, 31% of patients treated with Tremfya were considered cleared or almost cleared vs. 14% of patients treated with Stelara (ustekinumab; Janssen Biotech) at Week 28.
Tremfya is also being studied in a Phase 3 trial of patients with active psoriatic arthritis, and another Phase 3 program is underway to compare the efficacy of Tremfya vs. Cosentyx (secukinumab; Novartis) for the treatment of moderate to severe plaque psoriasis.
Tremfya will be available as a 100mg strength subcutaneous (SC) injection within two weeks.
For more information call (800) 526-7736 or visit TremfyaHCP.com.