Mumbai – October 30, 2026 -- The U.S. Food and Drug Administration has approved Sun Pharma's supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn) in adults with active psoriatic arthritis (PsA), the first expansion of the IL-23 inhibitor beyond plaque psoriasis since its 2018 U.S. approval.
Approval addresses a U.S. patient pool of about 2.4 million
Approximately 2.4 million Americans live with PsA, according to Sun Pharma. The company states that roughly 1 in 3 people with psoriasis also have PsA, and that more than 15% of psoriasis patients may have undiagnosed PsA.
ILUMYA was previously cleared only for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Provider-administered dosing defines the product's positioning
ILUMYA is administered exclusively by a healthcare provider. Rick Ascroft, North America CEO of Sun Pharma, said this makes it an option for PsA patients who cannot self-administer treatment or may benefit from regular in-office care.
Phase 3 INSPIRE-1 and INSPIRE-2 studies back the filing
The approval rests on two 52-week, global, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies of tildrakizumab 100 mg. They evaluated efficacy and safety at 24 weeks after only two doses in adults with active PsA.
Sun Pharma reports no new safety signals in either study. The most common adverse reactions in PsA, at a rate of 3% or higher, were upper respiratory tract infections and COVID-19. The label warns that ILUMYA may increase infection risk and requires TB evaluation before treatment starts.
Portfolio extends across geographies and partners
Outside the U.S., ILUMYA is approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan. In Europe it is sold as ILUMETRI and marketed by Almirall. Sun Pharma says innovative medicines account for about 20% of its sales.
ILUMYA is also the first biologic to earn the National Psoriasis Foundation Seal of Recognition.