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FDA Approves ILUMYA for Active Psoriatic Arthritis

lite News Desk 2 min read

ILUMYA (tildrakizumab-asmn) has received U.S. Food and Drug Administration approval for use in adults with active psoriatic arthritis, according to Sun Pharma’s October 30, 2026, announcement. The company said the FDA approved its supplemental biologics license application for the additional indication.

Sun Pharma said the medicine’s earlier U.S. approval covered moderate-to-severe plaque psoriasis in adults who qualify for systemic treatment or phototherapy. The October approval adds an adult psoriatic arthritis indication to that existing use. According to the company, ILUMYA is administered under the skin, and injections must be given by a healthcare provider.

The evidence supporting the approval came from INSPIRE-1 and INSPIRE-2, according to Sun Pharma. Both phase 3 trials studied a 100 mg dose of tildrakizumab in adults with active psoriatic arthritis over 52 weeks. Conducted internationally across multiple centers, the studies used random assignment, double blinding and placebo controls.

In its report on pooled data covering 806 participants, MDSpire News put the week-24 ACR20 response rate at 38.8% for tildrakizumab, compared with 24.4% for placebo. ACR20 requires improvement of at least 20% under criteria established by the American College of Rheumatology. The same report said the treatment groups’ Health Assessment Questionnaire-Disability Index scores did not differ to a statistically significant degree.

Sun Pharma said safety results from the psoriatic arthritis studies matched the medicine’s established safety profile and that the studies identified no new safety signals. Among patients with psoriatic arthritis, the company listed COVID-19 and upper respiratory tract infections as common adverse reactions.

The company describes tildrakizumab as an antibody targeting the p19 component of interleukin-23, or IL-23. By binding selectively to that component, the antibody inhibits IL-23’s interaction with its receptor, according to Sun Pharma’s description of the medicine’s mechanism.

A separate FDA labeling review dated March 16, 2026, provides the earlier regulatory context. That document listed two IL-23 antagonists, guselkumab, sold as Tremfya, and risankizumab, sold as Skyrizi, with indications for active psoriatic arthritis. In the same review, tildrakizumab, sold as ILUMYA, was listed for plaque psoriasis, before its additional indication received approval in October.

* This article is based on publicly available information at the time of writing.

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