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# FDA Accepts Sun Pharma Filing to Expand Ilumya Use
- URL: https://www.fdaweb.com/fda-accepts-sun-pharma-filing-to-expand-ilumya-use/
- Published: 2026-03-16T12:00:00.000Z
- Updated: 2026-09-14T13:35:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160825

FDA has accepted for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. If approved, the new indication would extend the use of the IL-23 inhibitor beyond its current authorization for moderate-to-severe plaque psoriasis. The FDA has set a target review action decision date of 10/29.

Ilumya was first approved in 2018 for adults with plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, additional label expansions have been granted, including approvals in 2024 and 2025 for scalp and nail psoriasis, respectively.

Sun Pharma says the latest filing is supported by results from two Phase 3 clinical trials — INSPIRE-1 and INSPIRE-2 — which evaluated the drug’s safety and efficacy in adults with active psoriatic arthritis.

Ilumya is a monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23, blocking its interaction with the IL-23 receptor and reducing inflammatory signaling, according to the company.