Sun Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has approved Ilumya for the treatment of adults with active psoriatic arthritis, broadening the medication’s therapeutic scope beyond its previous indication for plaque psoriasis.
Psoriatic arthritis is a chronic, immune-mediated condition characterized by joint pain, swelling, and stiffness that can result in irreversible joint damage. The disease impacts roughly 2.4 million individuals in the United States.
Ilumya (tildrakizumab-asmn) functions as a monoclonal antibody that specifically inhibits interleukin-23, a key protein driving inflammatory responses. Initially granted FDA approval in 2018, Ilumya has been indicated for adults with moderate-to-severe plaque psoriasis who are suitable candidates for systemic therapy or phototherapy.
The therapy has also received regulatory clearance for moderate-to-severe plaque psoriasis in several international markets, including India, Australia, Canada, China, and Japan. In Europe, it is marketed under the name Ilumetri by Almirall.
The new approval is backed by data from INSPIRE-1 and INSPIRE-2, two 52-week, global, randomized, double-blind, placebo-controlled Phase 3 trials evaluating Ilumya 100 mg in adults with active psoriatic arthritis. These studies measured both efficacy and safety outcomes at the 24-week mark following two initial doses.
Safety results aligned with Ilumya’s established profile, revealing no previously unidentified safety concerns. The most frequently reported adverse events among psoriatic arthritis patients included upper respiratory tract infections and COVID-19.
Rick Ascroft, CEO of Sun Pharma’s North American operations, noted that the healthcare provider-administered treatment offers a viable option for patients who cannot self-administer therapy or who may benefit from consistent in-office medical supervision.
Sun Pharma’s stock was trading 2.38% higher at INR1,802.90 on the National Stock Exchange.
