The US FDA has accepted for review Sun Pharmaceutical's Supplemental Biologics License Application (sBLA) for Ilumya (tildrakizumab-asmn).[1][2] The application relates to the treatment of adult patients with active psoriatic arthritis.[1][2] S BLA is based on the results of the phase 3 clinical trials INSPIRE-1 and INSPIRE-2.[1] In these studies, Ilumya demonstrated statistically significant improvements as measured by ACR20 response and psoriatic arthritis symptoms at week 24 versus placebo.[1] The ACR20 is a standardized measure of improvement in rheumatoid arthritis and other inflammatory rheumatic diseases.[1] Ilumya is currently approved for the treatment of moderate to severe plaque psoriasis and blocks the IL-23 subunit of the protein, which promotes inflammation.[1] Since its approval, doctors have prescribed it to nearly 140,000 patients worldwide with permanent skin clearing and a five-year safety profile.[1] In fiscal year 2025, it reached $681 million in net sales.[1]