Sun Pharma announces US FDA acceptance of sBLA application for ILUMYA to treat patients with active psoriatic arthritis

New Delhi: Sun Pharmaceutical Industries Limited has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis. The FDA regulatory action date for this sBLA is expected by October 29, 2026.

“For many people living with psoriatic disease, joint symptoms often add another layer of burden,” says Rick Ascroft, CEO, Sun Pharma North America. “As we continue to strengthen Sun Pharma’s innovative portfolio, we look forward to working with the 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.”

If approved, this would mark a new indication for ILUMYA following its US FDA approval in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Scalp and nail plaque psoriasis sBLAs were approved in April 2024, and December 2025, respectively. ILUMYA has also received marketing authorization from over 55 worldwide health authorities since its original approval, including in India, Japan, the European Union, China, Australia and Canada.

Since its approval, ILUMYA has supported nearly 140,000 patients worldwide with durable skin clearance and a well-characterized safety profile through 5 years of clinical follow-up. Additionally, real-world experience has shown strong adherence and persistence, helping patients stay on treatment long-term. ILUMYA has been endorsed widely by dermatologists in the US and globally as a trusted and effective treatment for adults with moderate-to-severe plaque psoriasis.

The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of ILUMYA in adult patients with active psoriatic arthritis. Top-line findings from these studies were reported in July 2025. Further details of the studies will be shared at a future congress.

Sun Pharma appreciates the tireless contributions of the participating clinical sites and the participants involved in the PsA investigational clinical trial program.

ILUMYA may cause serious side effects, including serious allergic reactions. Do not take ILUMYA if allergic to it. Seek emergency medical help right away for an allergic reaction. ILUMYA may increase risk of infections and lower ability to fight them. Call a doctor about any infection. Before starting, a doctor will check for infections and tuberculosis (TB). Consult a doctor before vaccinations; avoid live vaccines. Most common side effects are upper respiratory infections, injection site reactions, and diarrhea.