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WASHINGTON -- The FDA today approved the p19-selective interleukin (IL)-23 inhibitor tildrakizumab-asmn (Ilumya) for moderate or severe psoriasis, the drugmaker Sun Pharma .

The approval states that the drug is for patients who are candidates for systemic treatment or phototherapy.

Primary support for the approval application came from two phase III trials -- and -- that both met the primary endpoint of at least 75% improvement in the Psoriasis Area Sensitivity Index (PASI 75) and a physician's global assessment (PGA) score of 0 or 1 ("clear" or "minimal") after 12 weeks of treatment, according to data published last year in .

In reSURFACE1, 772 patients were randomized to two doses of tildrakizumab or to placebo. The reSURFACE2 trial evaluated two doses of tildrakizumab versus placebo or etanercept.

In both trials, more than 60% of patients randomized to tildrakizumab attained PASI 75 status compared with 6% of patients in the placebo groups and 48% for the etanercept arm of reSURFACE2. The proportion of patients achieving PGA 0 or 1 with tildrakizumab was 58% to 59% (depending on dose) in reSURFACE1 and 55% to 59% in resSURFACE2, as compared with 4% for placebo and 48% with etanercept.

More patients attained the primary endpoints with longer treatment and follow-up. In reSURFACE1, 74% of patients treated with the IL-23 inhibitor had PASI 75 improvement at 28 weeks and 84% at 64 weeks.

The most common adverse reactions (≥1% of patients) associated with tildrakizumab include upper respiratory infections, injection-site reactions and diarrhea.

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