The manufacturer of the interleukin-23 inhibitor tildrakizumab (Ilumya), Sun Pharma, announced today that the FDA has accepted its supplemental biologics license application for the indication of active psoriatic arthritis (PsA) in adults.
The manufacturer said it expects to have a decision from the agency by October 29, 2026. PsA would be the second major indication for the biologic since it was first approved in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, with subsequent approvals for scalp psoriasis in April 2024 and nail plaque psoriasis in December 2025.
In its announcement, Sun Pharma said that nearly 140,000 patients have been treated with tildrakizumab worldwide.
Sun Pharma conducted the INSPIRE-1 and INSPIRE-2 phase 3 clinical studies in more than 800 adults with active PsA to support its application and reported results in July 2025 but has yet to report the full findings. At 24 weeks, significantly more patients receiving tildrakizumab 100 mg met the endpoint of 20% improvement in American College of Rheumatology response criteria compared with placebo.
INSPIRE-1 enrolled patients having prior exposure to an anti-TNF agent while the INSPIRE-2 enrolled anti-TNF-naive patients; in both studies, treatment with either tildrakizumab or placebo was given at weeks 0 and 12. In each trial, patients were permitted to use concomitant methotrexate or leflunomide.
