FDA Approves Sun Pharma’s Ilumya for Active Psoriatic Arthritis

FDA has approved Sun Pharma’s tildrakizumab-asmn (Ilumya), an anti-IL-23 monoclonal antibody, for adults with active psoriatic arthritis (PsA).¹ The supplemental Biologics License Application (sBLA) expands the drug’s label beyond moderate-to-severe plaque psoriasis, for which it was first approved in 2018.¹

Ilumya is administered exclusively by a healthcare provider, which Sun Pharma is positioning as a differentiator. “ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care,” said Rick Ascroft, North America chief executive officer of Sun Pharma.¹

How does tildrakizumab work?

Tildrakizumab is a humanized IgG1/κ monoclonal antibody that selectively binds the p19 subunit of interleukin-23 (IL-23) and blocks its interaction with the IL-23 receptor, inhibiting the release of pro-inflammatory cytokines and chemokines.¹ Psoriatic arthritis is a chronic immune-mediated disease that causes pain, swelling, and stiffness in joints and entheses, the sites where tendons and ligaments attach to bone.¹ About 2.4 million Americans live with PsA, and roughly one in three people with psoriasis also have the condition.¹

What supported the approval?

The approval is based on the Phase 3 INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) trials, 52-week, randomized, double-blind, placebo-controlled studies that together enrolled more than 800 adults in the US, Europe, and Asia.¹˒² INSPIRE-1 enrolled patients previously treated with tumor necrosis factor (TNF) inhibitors, and INSPIRE-2 enrolled TNF inhibitor-naïve patients.²

Both trials met their primary endpoint, with a significantly greater proportion of patients receiving tildrakizumab 100 mg achieving at least a 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24 compared with placebo (P<.05).² Patients received the drug at Week 0 and every 12 weeks thereafter, without the Week 4 induction dose used in the plaque psoriasis trials, meaning efficacy at Week 24 reflects only two doses.¹˒³ Sun Pharma has not publicly reported response rates from either trial.²˒³

Safety was consistent with Ilumya’s established profile, with no new signals identified.¹ The most common adverse reactions in PsA, occurring in at least 3% of patients, were upper respiratory tract infections and COVID-19.¹

How does Ilumya fit among IL-23 inhibitors?

Ilumya becomes the third IL-23p19 inhibitor approved for PsA in the US. Johnson & Johnson’s guselkumab (Tremfya) was the first, approved in July 2020, followed by AbbVie’s risankizumab (Skyrizi) in January 2022.⁴˒⁵

Sun Pharma’s in-office model contrasts with the industry’s broader shift toward at-home administration. Earlier this month, BioPharm International® reported that FDA approved a subcutaneous on-body injector induction regimen for Skyrizi in Crohn’s disease, allowing patients to start treatment at home.

“Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team,” said Philip Mease, MD, director of rheumatology research at Swedish Medical Center and Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine.¹

The push toward home administration reflects how much patients value flexibility in immune-mediated diseases. In a BioPharm International interview, Juby Jacob-Nara, MD, chief medical officer and senior vice president at Celltrion, said the company’s subcutaneous infliximab, which patients can take outside an infusion center, “is a game changer for patients with IBD.”

What happens next?

Sun Pharma said full INSPIRE-1 and INSPIRE-2 results would be presented at medical conferences and published in a peer-reviewed journal.³ Outside the US, tildrakizumab is approved for plaque psoriasis in India, Australia, Canada, China, and Japan, and is marketed in Europe as Ilumetri by Almirall.¹

References

1. ILUMYA (tildrakizumab-asmn) approved in the U.S. for the treatment of adults with active psoriatic arthritis. News release. Sun Pharma. October 30, 2026. Accessed October 30, 2026.
2. Sun Pharma’s Phase 3 clinical studies evaluating tildrakizumab 100 mg (ILUMYA) in active psoriatic arthritis meet their primary endpoint. News release. Sun Pharma. July 21, 2025. Accessed October 30, 2026.
3. FDA accepts Sun Pharma sBLA to expand tildrakizumab to psoriatic arthritis. Rheum Live. March 19, 2026. Accessed October 30, 2026.
4. Tremfya (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis. News release. Johnson & Johnson. July 14, 2020. Accessed October 30, 2026.
5. U.S. FDA approves second indication for SKYRIZI (risankizumab-rzaa) to treat adults with active psoriatic arthritis. News release. AbbVie. January 21, 2022. Accessed October 30, 2026.