Sun Pharma Advances ILUMYA with FDA Review for Psoriatic Arthritis
Tuesday, March 17, 2026
Sun Pharmaceutical Industries Limited has announced that the US Food and Drug Administration has accepted its supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis.
Psoriatic arthritis is a chronic immune-mediated condition that causes joint pain, swelling and stiffness. It may also affect areas where tendons and ligaments attach to bone. The condition can occur at any age and often develops in people with psoriasis. Around one in three individuals with psoriasis may develop psoriatic arthritis, although a significant proportion remain undiagnosed.
ILUMYA is a monoclonal antibody that targets the interleukin-23 (IL-23) pathway, which plays a key role in inflammatory processes. By blocking this pathway, the treatment helps reduce inflammation associated with psoriasis.
The application seeks to expand the use of ILUMYA beyond its current approval. The medicine was first approved in 2018 for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy. Additional approvals for scalp and nail psoriasis were granted in 2024 and 2025. ILUMYA is now authorised in more than 55 countries, including India, Japan, the European Union, China, Australia and Canada.
Since its launch, ILUMYA has been used to treat nearly 140,000 patients globally. Long-term clinical data over five years indicate sustained skin clearance and a consistent safety profile. Real-world data also suggest good treatment adherence and persistence among patients.
The current sBLA submission is based on results from the Phase 3 INSPIRE-1 and INSPIRE-2 studies. These were 52-week, global, randomised, double-blind, placebo-controlled trials assessing the efficacy and safety of ILUMYA 100 mg in adults with active psoriatic arthritis. Initial results were reported in July 2025, with further detailed findings expected to be presented at a future scientific meeting.
The therapy carries certain safety considerations. It may increase the risk of infections and can cause allergic reactions in some patients. Screening for infections, including tuberculosis, is required before starting treatment. Common side effects include upper respiratory infections, injection site reactions and diarrhoea.
Source: sunpharma.com
