On October 30, 2026, the FDA approved Sun Pharma's supplemental Biologics License Application for Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. Supported by the Phase 3 INSPIRE-1 and INSPIRE-2 trials showing significant ACR20 improvements at 24 weeks, this decision provides a healthcare provider-administered IL-23 inhibitor option for the estimated 2.4 million Americans with the condition, joining existing targeted treatments like guselkumab and risankizumab.
FDA approval and background
- ▪The FDA approved Sun Pharma's supplemental Biologics License Application for Ilumya to treat adults with active psoriatic arthritis
- ▪The FDA initially accepted Sun Pharma's supplemental Biologics License Application for tildrakizumab in active psoriatic arthritis in March 2026
- ▪The FDA's approval of Ilumya for active psoriatic arthritis expands its use beyond moderate-to-severe plaque psoriasis, for which the drug was initially cleared in 2018
Phase 3 INSPIRE trial results
- ▪The FDA approval of tildrakizumab (Ilumya) for psoriatic arthritis was supported by 52-week Phase 3 INSPIRE-1 and INSPIRE-2 studies evaluating tildrakizumab 100 mg in over 800 adults with active psoriatic arthritis
- ▪Sun Pharma said that at 24 weeks in the INSPIRE-1 and INSPIRE-2 trials, significantly more patients receiving subcutaneous tildrakizumab 100 mg achieved ACR20 response compared to placebo after two doses
- ▪In the INSPIRE-1 and INSPIRE-2 Phase 3 trials, the most common adverse reactions reported in at least 3% of psoriatic arthritis patients were upper respiratory tract infections and COVID-19
Psoriatic arthritis prevalence and impact
- ▪Roughly 1 in 3 people living with psoriasis also develop psoriatic arthritis, and more than 15% of people with psoriasis may have undiagnosed psoriatic arthritis
- ▪Approximately 2.4 million Americans live with psoriatic arthritis, a chronic immune-mediated disease causing joint pain, swelling, stiffness, and potential permanent joint damage
Other approved biologic therapies
- ▪Tildrakizumab is the third IL-23 inhibitor approved for psoriatic arthritis, following guselkumab (Tremfya) in 2020 and risankizumab (Skyrizi) in 2022
- ▪The FDA cleared the IL-12/23 inhibitor ustekinumab (Stelara) for psoriatic arthritis in 2013
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