MUMBAI, India and PRINCETON, New Jersey, U.S., October 30, 2026
Sun Pharmaceutical Industries Limited (Sun Pharma) has announced that the U.S. Food and Drug Administration (FDA) has approved ILUMYA® (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA). The approval follows the FDA’s review of the company’s supplemental Biologics License Application (sBLA) and expands ILUMYA’s use beyond its previously approved indication for moderate-to-severe plaque psoriasis in adults. The newly approved indication introduces another treatment option for people living with this chronic inflammatory condition, which can affect joints, tendons and other structures. ILUMYA is an interleukin-23 (IL-23) inhibitor administered exclusively by healthcare professionals. Sun Pharma said the expanded indication strengthens its portfolio in psoriatic disease and provides an additional option for patients who may have difficulty self-administering injectable medicines or prefer regular treatment under medical supervision.
FDA Approval Expands ILUMYA’s Use in Psoriatic Arthritis
ILUMYA contains tildrakizumab-asmn, a humanized monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23. By inhibiting the interaction of IL-23 with its receptor, the medicine reduces the release of inflammatory cytokines and chemokines involved in immune-mediated disease. IL-23 is an important component of inflammatory pathways associated with psoriasis and psoriatic arthritis. The FDA approval allows ILUMYA to be used in adults with active PsA, expanding its established role in moderate-to-severe plaque psoriasis. A key feature of ILUMYA is that it is administered by a healthcare provider, rather than being intended for routine self-injection by patients. This may offer a useful treatment arrangement for individuals who cannot self-administer injections or who benefit from scheduled clinical visits. The expanded indication is particularly relevant because psoriatic arthritis can cause persistent joint pain, swelling and stiffness, potentially resulting in permanent joint damage when inflammation is not adequately controlled. The condition may also occur in people with different levels of skin psoriasis severity, making individualized treatment approaches important.
Phase 3 INSPIRE Studies Supported the Approval
The FDA decision was supported by results from two global Phase 3 clinical studies, INSPIRE-1 and INSPIRE-2, which evaluated the efficacy and safety of tildrakizumab in adults with active psoriatic arthritis. Both studies were designed as 52-week, multicenter, randomized, double-blind and placebo-controlled trials. The clinical programme assessed tildrakizumab 100 mg and evaluated treatment outcomes following only two doses at Week 24. The studies provided evidence for the FDA’s assessment of the medicine’s potential role in managing active PsA. According to Sun Pharma, the safety findings were consistent with ILUMYA’s established safety profile, and no new safety signals were identified in the two studies. The company’s announcement highlights the clinical evidence supporting the expanded indication while reinforcing the importance of continued monitoring during treatment. ILUMYA may increase the risk of infections, and patients should be evaluated for tuberculosis before starting therapy. Healthcare professionals should also consider vaccination status and avoid administering live vaccines during treatment. Serious allergic reactions are another important consideration, and treatment should be discontinued if a serious hypersensitivity reaction occurs.
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Sun Pharma Strengthens Its Inflammatory Disease Portfolio
The approval marks a further development in Sun Pharma’s efforts to expand treatment options for people living with inflammatory and immune-mediated conditions. Approximately 2.4 million people in the United States are estimated to live with psoriatic arthritis, according to the company’s announcement. The condition is associated with joint inflammation and can significantly affect mobility, daily activities and quality of life. Rick Ascroft, North America CEO of Sun Pharma, described the FDA decision as an important milestone for the company and its innovative medicines portfolio. He highlighted ILUMYA’s healthcare provider-administered approach as a potential advantage for appropriate patients. Philip Mease, Director of Rheumatology Research at Swedish Medical Center and Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine, also emphasized the need for a range of treatment choices that allow clinicians to individualize care according to patients’ symptoms and treatment goals.
Originally approved in the United States in 2018 for moderate-to-severe plaque psoriasis, ILUMYA now has an expanded role in the management of psoriatic disease. The new FDA indication provides physicians with another IL-23-targeted biologic option for adults with active psoriatic arthritis. The approval also highlights the continued importance of clinical research into targeted therapies for chronic inflammatory disorders. Sun Pharma said the milestone builds on its experience with ILUMYA and its commitment to supporting patients and healthcare professionals. As treatment strategies continue to evolve, the medicine’s expanded indication may contribute to a broader range of choices for managing psoriatic arthritis.
Source: Sun Pharma press release
