India-based pharmaceutical company Sun Pharmaceutical Industries Limited (NSE: SUNPHARMA, BSE: 524715) said on Friday that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn) to treat adults with active psoriatic arthritis.

The approval expands the use of ILUMYA beyond moderate-to-severe plaque psoriasis, for which the IL-23 inhibitor was approved by the FDA in 2018.

The decision was supported by the Phase 3 INSPIRE-1 and INSPIRE-2 studies, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis after two doses over 24 weeks. Both 52-week, global, multicentre, randomised, double-blind, placebo-controlled trials assessed tildrakizumab 100mg in adult patients with the disease.

Sun Pharma said safety findings in the studies were consistent with ILUMYA's established safety profile, with no new safety signals identified.

Approximately 2.4 million Americans live with psoriatic arthritis, a condition that can cause joint pain, swelling and stiffness, and may lead to permanent joint damage. ILUMYA is administered exclusively by a healthcare provider and offers a treatment option for patients who are unable to self-administer therapy or may benefit from regular in-office care.