Sun Pharma Seeks FDA Approval for ILUMYA in Psoriatic Arthritis

If approved, the expanded indication would build on ILUMYA's established use for moderate-to-severe plaque psoriasis.

Mar. 16, 2026 at 4:00pm

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

Why it matters

With 1 in 3 psoriasis patients developing psoriatic arthritis, Sun Pharma's pursuit of this expanded indication for ILUMYA could provide an important new treatment option for patients living with the joint and skin symptoms of psoriatic disease.

The details

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.

  • The FDA regulatory action date for this sBLA is expected by October 29, 2026.

The players

Sun Pharmaceutical Industries Limited

A global pharmaceutical company and the largest drug maker in India, known for its specialty generics, innovative medicines, and consumer healthcare products.

ILUMYA (tildrakizumab-asmn)

A humanized monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and is approved for the treatment of adults with moderate-to-severe plaque psoriasis in several countries, including the United States.

US Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

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What they’re saying

“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.”

— Rick Ascroft, CEO, Sun Pharma North America

What’s next

The FDA is expected to make a decision on the sBLA by October 29, 2026.

The takeaway

If approved, the expanded indication for ILUMYA would provide a new treatment option for the significant population of psoriasis patients who also develop the joint symptoms of psoriatic arthritis, addressing an important unmet medical need.