Sun Pharmaceutical Industries Limited has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for ILUMYA, seeking approval for the treatment of adults with active psoriatic arthritis. The regulatory decision is expected by October 29, 2026, marking a key milestone in the company’s efforts to expand the drug’s therapeutic use.
ILUMYA, a biologic therapy targeting interleukin-23 (IL-23), is currently approved in the United States for the treatment of adults with moderate-to-severe plaque psoriasis. First cleared by the FDA in 2018, the drug has since seen additional label expansions, including approvals for scalp psoriasis in April 2024 and nail psoriasis in December 2025. If the latest application is approved, it would represent a significant extension into psoriatic arthritis, a chronic inflammatory condition that affects both the skin and joints.
Rick Ascroft, CEO of Sun Pharma North America, emphasized the unmet need among patients with psoriatic disease, noting that joint involvement often adds a substantial burden to those already managing skin symptoms. He stated that the company aims to position ILUMYA as a differentiated, first-choice advanced systemic therapy, highlighting its status as the only healthcare provider-administered IL-23 biologic in its class.
The sBLA submission is supported by data from two Phase 3 clinical trials, INSPIRE-1 and INSPIRE-2, which evaluated the safety and efficacy of ILUMYA in adults with active psoriatic arthritis. Top-line results from these studies were released in July 2025, with more detailed findings expected to be presented at an upcoming scientific congress.
Globally, ILUMYA has gained marketing authorization in more than 55 countries, including major markets such as India, Japan, the European Union, China, Australia, and Canada. Since its initial approval, the therapy has been used by nearly 140,000 patients worldwide, demonstrating durable skin clearance and a well-established safety profile over five years of clinical follow-up.
In addition to clinical trial data, real-world evidence has indicated strong patient adherence and persistence with ILUMYA treatment, factors that are critical for long-term disease management. The drug has also received widespread endorsement from dermatologists globally as a reliable option for moderate-to-severe plaque psoriasis.
Sun Pharma acknowledged the contributions of clinical investigators and trial participants involved in the psoriatic arthritis development program. As the FDA review process progresses, the company will continue to engage with regulators in anticipation of a potential new treatment option for patients living with this debilitating condition.
ILUMYA’s safety profile includes potential risks such as serious allergic reactions and increased susceptibility to infections. Patients are advised to consult healthcare providers regarding screening for infections, including tuberculosis, prior to initiating therapy.