Johnson & Johnson (J&J) has submitted a supplemental Biologics License Application to the US Food and Drug Administration, seeking a label update for Tremfya (guselkumab).
The application seeks to include new evidence showing significant inhibition of joint structural damage in adults with active psoriatic arthritis.
Developed by J&J, Tremfya is a fully-human, dual-acting monoclonal antibody that targets inflammation by blocking IL-23 and binding to CD64.
The drug is approved in Canada, Europe, Japan, and other countries for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults.
J&J’s submission is backed by the Phase 3b APEX study, which met its primary endpoint of reducing joint symptoms and a secondary endpoint of inhibiting structural damage progression.
APEX is a multicentre, randomised, double-blind, placebo-controlled trial in biologic-naïve patients with active psoriatic arthritis who are not responsive to standard therapies.
The study includes a 24-week placebo-controlled period, followed by a 24-week active treatment period, with an option for a two-year extension.
Data from the APEX study aligns with Tremfya’s established safety profile.
Johnson & Johnson Innovative Medicine medical affairs, dermatology and rheumatology vice president Brandee Pappalardo said: “Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition.
“With this new evidence, Tremfya would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA.”
