Sun Pharma's Tildrakizumab Advances into Psoriatic Arthritis as FDA Accepts sBLA

FDA has accepted for review a supplemental biologics license application (sBLA) from Sun Pharmaceutical Industries (Sun Pharma) for its tildrakizumab-asmn (brand name Ilumya), a humanized immunoglobulin G1-kappa monoclonal antibody (mAb), for treating adults with active psoriatic arthritis (PsA), the company announced on March 16, 2026. The company expects the FDA regulatory action date for this sBLA by Oct. 29, 2026.¹

If approved, the indication would represent a meaningful expansion for the mAb, which first received FDA approval in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.² Supplemental BLAs for scalp and nail plaque psoriasis indications were approved in April 2024 and December 2025, respectively.¹

What clinical evidence supports the sBLA for psoriatic arthritis?

The sBLA is supported by data from two Phase III clinical studies (INSPIRE-1 and INSPIRE-2) evaluating the efficacy and safety of tildrakizumab in adult patients with active PsA. Top-line findings from these studies were reported in July 2025.³ The INSPIRE-1 trial enrolled patients with prior exposure to anti-tumor necrosis factor (TNF) therapies, while INSPIRE-2 focused on anti-TNF-naive patients, with more than 800 adult participants enrolled across clinical sites in the United States, Europe, and Asia. Tildrakizumab was administered at Week 0 and every 12 weeks thereafter, with no induction dose required.^4,5

Both studies met their primary endpoint with tildrakizumab treatment at a dose of 100 mg demonstrating greater improvements in PsA signs and symptoms compared to placebo. Across both studies, tildrakizumab demonstrated statistically significant ACR20 response rates versus placebo at Week 24, with safety findings consistent with the biologic’s established psoriasis safety profile and no new signals identified.

How could tildrakizumab expand treatment options for patients with active PsA?

Tildrakizumab functions as a selective inhibitor of interleukin-23 (IL-23), a cytokine implicated in both cutaneous and articular manifestations of psoriatic disease. While several IL-23 inhibitors have been approved for both plaque psoriasis and psoriatic arthritis, tildrakizumab had previously lacked PsA-specific clinical data of sufficient scale to support a regulatory filing, a gap the INSPIRE program was designed to address.³

"For many people living with psoriatic disease, joint symptoms often add another layer of burden," said Rick Ascroft, CEO of Sun Pharma North America, in a company press release.¹ "As we continue to strengthen Sun Pharma's … portfolio, we look forward to working with [FDA] throughout the review process. As the only HCP-administered IL-23 biologic, our ambition is that [Ilumya] becomes a differentiated first-choice advanced systemic treatment for active psoriatic arthritis."

What role do IL-23 inhibitors play in managing PsA and psoriasis?

PsA affects an estimated 2.4 million Americans, and nearly a third of psoriasis patients may go on to develop the joint condition, many of whom remain undiagnosed or undertreated. Standard advanced treatment options include TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, and JAK inhibitors, though durable responses remain elusive for a meaningful proportion of patients. This lack of durable responses underscores the continued need for differentiated options in this space.^6,7

Tildrakizumab, under the Ilumya name, has received marketing authorization from more than 55 health authorities worldwide since its original approval, including in India and Japan. Sun Pharma noted that further clinical details from the INSPIRE studies will be shared at a future scientific congress.¹

References

1. Sun Pharmaceutical Industries. 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. Press Release. March 16, 2026.
2. Sun Pharmaceutical Industries. Sun Pharma Announces US FDA Approval of ILUMYA (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis. Press Release. March 21, 2018.
3. Sun Pharmaceutical Industries. Sun Pharma’s Phase 3 Clinical Studies Evaluating Tildrakizumab 100 mg (ILUMYA) in Active Psoriatic Arthritis Meet their Primary Endpoint. Press Release. July 21, 2025.
4. Sun Pharmaceutical Industries. Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1). ClinicalTrials.gov. Last updated Jan. 16, 2026. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT04314544
5. Sun Pharmaceutical Industries. Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2). ClinicalTrials.gov. Last updated March 10, 2026. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT04314531
6. Pratt E. Psoriatic Arthritis Statistics. Verywellhealth.com. Updated Jan. 5, 2026. Accessed March 16, 2026. https://www.verywellhealth.com/psoriatic-arthritis-statistics-5196457
7. National Psoriasis Foundation. Psoriasis Statistics. Psoriasis.org. Accessed March 16, 2026. https://www.psoriasis.org/psoriasis-statistics/