Sun Pharma’s ILUMYA (tildrakizumab) sBLA for the treatment of active psoriatic arthritis has been accepted for review by the FDA, with a regulatory decision expected by October 29, 2026
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Sun Pharmaceutical Industries Ltd. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA). The FDA has assigned a regulatory action date of October 29, 2026.
The submission is supported by results from the Phase 3 INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) clinical trials, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis. Both studies were 52-week, global, multicenter, randomized, double-blind, placebo-controlled trials assessing tildrakizumab 100 mg.
Both studies met their primary endpoint, demonstrating that a significantly higher proportion of patients treated with tildrakizumab achieved an ACR20 response at Week 24 compared with placebo (p < 0.05). Treatment with ILUMYA also led to meaningful improvements in the signs and symptoms of psoriatic arthritis, while the safety profile remained consistent with previous studies in plaque psoriasis and no new safety signals were identified. The global studies enrolled more than 800 patients across the United States, Europe, and Asia, including patients with prior exposure to anti-TNF therapy and those who were biologic-naive.
Additional detailed results expected to be presented at a future scientific congress.
If approved, the new indication would expand ILUMYA’s use beyond its current approval. The biologic was first approved by the FDA in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Additional supplemental approvals followed for scalp psoriasis in April 2024 and nail psoriasis in December 2025.
ILUMYA is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23). By blocking IL-23 signaling, the therapy inhibits the release of pro-inflammatory cytokines and chemokines involved in the pathogenesis of psoriasis and psoriatic arthritis.
According to Sun Pharma, ILUMYA has supported nearly 140,000 patients worldwide since its initial approval, demonstrating durable skin clearance and a well-characterized safety profile with up to five years of clinical follow-up. The therapy has received marketing authorization from more than 55 health authorities globally, including in the United States, India, Japan, the European Union, China, Australia, and Canada.
Psoriatic arthritis is a chronic immune-mediated disease characterized by joint pain, swelling, stiffness, and inflammation of entheses, the sites where tendons and ligaments attach to bone. The condition affects roughly one-third of people living with psoriasis, and an estimated 2.4 million people in the United States are living with the disease, with many additional cases believed to remain undiagnosed.
ILUMYA may cause serious side effects, including serious allergic reactions and increased risk of infections. Patients should be screened for infections such as tuberculosis (TB) before starting therapy and should avoid live vaccines during treatment. The most common adverse reactions reported with ILUMYA include upper respiratory infections, injection-site reactions, and diarrhea.
For complete prescribing information, including indications, safety data, warnings, and precautions, refer to the official ILUMYA Prescribing Information.
References
Sun Pharma Announces US FDA Acceptance of Supplemental Biologics License (sBLA) Application for ILUMYA® (tildrakizumab-asmn) for the Treatment of Adults with Active Psoriatic Arthritis, 16 March 2026, https://sunpharma.com/wp-content/uploads/2026/03/Sun-Pharma-Announces-US-FDA-Acceptance-of-sBLA-Application-for-ILUMYA.pdf
Sun Pharma’s Phase 3 Clinical Studies Evaluating Tildrakizumab 100 mg (ILUMYA®) in Active Psoriatic Arthritis Meet their Primary Endpoint, 21 July 2026, https://sunpharma.com/wp-content/uploads/2025/07/Press-Release-Phase-3-Clinical-Studies-PsA-ILUMYA-Topline.pdf
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects with Active Psoriatic Arthritis I (INSPIRE 1), ClinicalTrials.gov ID NCT04314544, https://clinicaltrials.gov/study/NCT04314544
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects with Active Psoriatic Arthritis II (INSPIRE 2), ClinicalTrials.gov ID NCT04314531, https://clinicaltrials.gov/study/NCT04314531
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. Along with this she also interested in wellness and healthcare writing due to her natural interest in those topics. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.