FDA Approves Tildrakizumab for Adults With Active Psoriatic Arthritis

Key Clinical Summary

• The US Food and Drug Administration approved tildrakizumab-asmn (Ilumya), an interleukin-23 inhibitor administered by healthcare providers, for adults with active psoriatic arthritis.
• Approval was supported by the phase 3 INSPIRE-1 and INSPIRE-2 trials, which demonstrated superiority of tildrakizumab over placebo for the primary endpoint of ACR20 response at 24 weeks.
• No new safety signals were identified. Tildrakizumab may increase infection risk, and patients should undergo tuberculosis evaluation before treatment.

The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (Ilumya) for adults with active psoriatic arthritis (PsA), Sun Pharmaceutical Industries Limited announced October 30, 2026.

The supplemental Biologics License Application approval expands the indication for the interleukin-23 (IL-23) inhibitor, which received FDA approval in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Study Findings

The approval was supported by INSPIRE-1 and INSPIRE-2, two 52-week, global, multicenter, randomized, double-blind, placebo-controlled phase 3 studies evaluating the efficacy and safety of tildrakizumab 100 mg in adults with active PsA.

Safety findings were consistent with the established safety profile of tildrakizumab, and no new safety signals were identified in either study, the company reported.

The announcement identified upper respiratory tract infections and COVID-19 as the most common adverse reactions in PsA, occurring at a frequency of at least 3%. For plaque psoriasis, adverse reactions occurring at a frequency of at least 1% included upper respiratory infections, injection site reactions, and diarrhea.

Tildrakiizumab may increase the risk of infection. Patients should be evaluated for tuberculosis infection before treatment begins.

Clinical Implications

Approximately 2.4 million Americans live with PsA, according to the announcement. The disease can cause joint pain, swelling, and stiffness that may lead to permanent joint damage.

The expanded indication adds a healthcare provider–administered IL-23 inhibitor option for adults with active disease.

The approval expands tildrakizumab’s use from plaque psoriasis to active PsA in US adults.

Reference

Sun Pharma. ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the treatment of adults with active psoriatic arthritis. News release. PR Newswire. October 30, 2026.