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The pharma firm added that ILUMYA has received marketing authorisation from more than 55 health authorities worldwide since its original approval, including in India, Japan, the European Union, China, Australia and Canada.
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Sun Pharmaceutical Industries Limited said on Monday, March 16, that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis.
The FDA’s regulatory action date for the application is expected by October 29, 2026.
“For many people living with psoriatic disease, joint symptoms often add another layer of burden,” said Rick Ascroft, CEO, Sun Pharma North America.
He added that the company looks forward to working with the FDA during the review process and aims for ILUMYA to become a differentiated first-choice advanced systemic treatment for active psoriatic arthritis.
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The pharma company said that if approved, the application would add a new indication for ILUMYA. The therapy was approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Supplemental approvals for scalp and nail plaque psoriasis were granted in April 2024 and December 2025, respectively.
The pharma firm added that ILUMYA has received marketing authorisation from more than 55 health authorities worldwide since its original approval, including in India, Japan, the European Union, China, Australia and Canada.
The sBLA submission is based on results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of ILUMYA in adults with active psoriatic arthritis. Top-line results from the studies were reported in July 2025, with further details expected to be presented at a future congress, said the company.
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The firm warned that ILUMYA may cause serious side effects, including serious allergic reactions, and should not be taken by patients allergic to the drug. It may increase the risk of infections and reduce the body’s ability to fight them.
Shares of Sun Pharmaceutical Industries Ltd ended at ₹1,776 on the Stock Exchange of India on March 16, down ₹25.60 or 1.42% for the day.
