The FDA has approved Sun Pharma’s Ilumya for adults with active psoriatic arthritis, expanding the medicine’s use beyond plaque psoriasis to a disease affecting approximately 2.4 million Americans.
Sun Pharma announced the approval October 30. Ilumya, or tildrakizumab-asmn, is an IL-23 inhibitor administered exclusively by healthcare providers rather than patients themselves.
The decision followed the FDA’s review of a supplemental biologics license application supported by two Phase 3 trials, INSPIRE-1 and INSPIRE-2.
The global, multicenter studies evaluated 100 milligrams of tildrakizumab in adults with active psoriatic arthritis. Both were randomized, double-blind and placebo-controlled, with a planned duration of 52 weeks.
The approval announcement described efficacy and safety assessments at week 24 after two doses. Sun Pharma said safety findings were consistent with Ilumya’s established profile and that neither study identified new safety signals.
Ilumya may increase infection risk, and patients should undergo evaluation for tuberculosis before starting treatment. The most common adverse reactions reported in psoriatic arthritis were upper respiratory tract infections and COVID-19, each occurring in at least 3% of patients.
Psoriatic arthritis can cause joint pain, swelling and stiffness, potentially leading to permanent joint damage.
Ilumya first received FDA approval in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Sun Pharma’s North America chief executive, Rick Ascroft, said healthcare provider administration offers an option for patients unable to self-administer treatment or needing regular office-based care. Sun Pharma appointed Ascroft to lead its North American operations in June 2025.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!