Sun Pharmaceutical announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics Licence Application (sBLA) for ILUMYA to treat adults with active psoriatic arthritis. The FDA regulatory action date for this sBLA is expected by 29 October, 2026.

“For many people living with psoriatic disease, joint symptoms often add another layer of burden. 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,” said Rick Ascroft, CEO, Sun Pharma North America.

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 authorisation 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-characterised safety profile through five years of clinical follow-up.

The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 phase-III 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.