Sun Pharma's ILUMYA Gets USFDA Review Nod for Psoriatic Arthritis Indication
New Delhi: Sun Pharmaceutical Industries Limited has announced that the US Food and Drug Administration (USFDA) has accepted for review its supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis.
The regulatory decision on the application is expected by October 29, 2026. If approved, the expanded indication would build on ILUMYA’s established use as an IL-23 inhibitor for moderate-to-severe plaque psoriasis.
Highlighting the significance of the development, Rick Ascroft, CEO of Sun Pharma North America, stated that joint symptoms add an additional burden for many patients with psoriatic disease. He added that the company looks forward to working with the US FDA during the review process and aims to position ILUMYA as a differentiated first-choice advanced systemic treatment for active psoriatic arthritis.
ILUMYA was initially approved by the US FDA in 2018 for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, additional approvals have been granted for scalp plaque psoriasis in April 2024 and nail plaque psoriasis in December 2025. The therapy has received marketing authorization from more than 55 global health authorities, including in India, Japan, the European Union, China, Australia, and Canada.
The drug 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. Real-world data also indicate strong adherence and persistence among patients undergoing treatment.
The sBLA submission is supported by findings from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical trials, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis. These global, randomized, double-blind, placebo-controlled studies spanned 52 weeks, with top-line results reported in July 2025.
Psoriatic arthritis is a chronic immune-mediated condition characterized by joint pain, stiffness, and swelling, and it can occur regardless of psoriasis severity. Approximately one in three individuals with psoriasis may develop psoriatic arthritis, while a significant proportion remain undiagnosed.
ILUMYA (tildrakizumab-asmn) is a humanized monoclonal antibody that selectively targets the p19 subunit of interleukin-23 (IL-23), inhibiting inflammatory pathways. It is currently indicated for adults with moderate-to-severe plaque psoriasis eligible for systemic therapy or phototherapy.
The drug carries important safety considerations, including risks of serious allergic reactions and infections. Patients are advised to undergo screening for infections such as tuberculosis before initiating treatment and to avoid live vaccines during therapy. Common adverse reactions include upper respiratory infections, injection site reactions, and diarrhea.
Sun Pharma stated that it remains committed to advancing treatment options for patients living with psoriatic disease, particularly given the significant proportion of psoriasis patients who develop psoriatic arthritis.
