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# Sun Pharma’s Ilumya Approved for Psoriasis
- URL: https://www.fdaweb.com/sun-pharmas-ilumya-approved-for-psoriasis/
- Published: 2018-03-21T12:00:00.000Z
- Updated: 2026-09-14T23:54:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141031

FDA has approved a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, which inhibits the release of pro-inflammatory cytokines and chemokines, according to the company. Approval was supported by data from the pivotal Phase-3 reSURFACE clinical development program. In the two multicenter, randomized, double-blind, placebo-controlled trials, 926 adult patients were treated with Ilumya (N=616) or placebo (N=310). Both met the primary efficacy endpoints, demonstrating significant clinical improvement with ILUMYA 100 mg compared to placebo when measured by at least 75% of skin clearance and the Physician's Global Assessment score of “clear” or “minimal” at week 12 after two doses.