Sun Pharmaceutical Industries has announced a major regulatory milestone: the US FDA has accepted its supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. The FDA’s decision is expected by October 29, 2026.

 

“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,” Sun Pharma noted.

 

“For many people living with psoriatic disease, joint symptoms often add another layer of burden,” said 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.”

 

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025, respectively, and holds marketing authorizations in more than 55 countries, including India, Japan, the EU, China, Australia, and Canada. Since its launch, nearly 140,000 patients worldwide have benefited from durable skin clearance and a strong safety profile over five years of clinical follow-up. Real-world data also show high adherence and persistence, making ILUMYA a trusted treatment among dermatologists globally.

 

The sBLA submission is based on INSPIRE-1 and INSPIRE-2 Phase 3 trials, which evaluated ILUMYA’s safety and efficacy in adults with active psoriatic arthritis. Top-line results were reported in July 2025, with full data set to be shared at an upcoming medical congress.

 

With one in three psoriasis patients developing psoriatic arthritis, Sun Pharma emphasizes its commitment to improving care for those living with psoriatic disease.