
Sun Pharmaceutical Industries announced the United States Food and Drug Administration (USFDA) has accepted its supplemental Biologics License Application (sBLA) seeking approval to use Ilumya for adults with active psoriatic arthritis.
As per a filing, the regulator has set October 29, 2026, as the target date to decide on the application.
If cleared, the therapy would be allowed for an additional medical condition linked to psoriasis. Ilumya is currently approved in the United States for adults with moderate-to-severe plaque psoriasis who require systemic treatment or phototherapy.
The application is supported by results from 2 late-stage studies, INSPIRE-1 and INSPIRE-2, which examined the safety and effectiveness of the drug in adults with active psoriatic arthritis.
Both trials were global, multicentre, randomised and placebo-controlled studies conducted over 52 weeks.
Initial findings from these trials were reported in July 2025. Additional details are expected to be shared at a future medical meeting, according to the company.
Ilumya, also known as tildrakizumab, works by targeting the interleukin-23 (IL-23) pathway involved in inflammatory responses associated with psoriasis. The drug received its first approval from the US regulator in 2018 for plaque psoriasis.
Further approvals have followed in recent years. Indications covering scalp psoriasis were cleared in April 2024, while an approval related to nail psoriasis came in December 2025.
Psoriatic arthritis is a chronic immune-related condition that causes joint pain, swelling and stiffness. Medical estimates indicate that about 1 in 3 people living with psoriasis may later develop psoriatic arthritis.
Ilumya has received marketing approvals from more than 55 health authorities worldwide, including regulators in India, Japan, the European Union, China, Australia and Canada.
According to company data, the treatment has been used by nearly 140,000 patients globally, with clinical follow-up extending up to 5 years.
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As of March 17, 2026, 9:51 am, Sun Pharmaceutical Industries Ltd share price stood at ₹1,793.60, a 0.58% decrease from the previous closing price.
The acceptance of the application allows the US regulator to begin a formal review of Ilumya for psoriatic arthritis. The outcome of the review will determine whether the drug’s approved use in the United States is expanded to include the condition.
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Published on: Mar 17, 2026, 10:15 AM IST

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