Sun Pharma announced that the Biologics License Application (BLA) for tildrakizumab has been accepted by the Food and Drug Administration (FDA).
Tildrakizumab, an anti-IL-23p19 monoclonal antibody, is being investigated as a treatment for moderate-to-severe plaque psoriasis. The mechanism of action is designed to selectively block the cytokine IL-23, and in doing so influencing the pathogenic cells responsible for the inflammatory course of psoriasis.
Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA. The trials are assessing the efficacy of tildrakizumab in moderate-to-severe plaque psoriasis in three parts; part 1 randomized patients to tildrakizumab 200mg or 100mg, placebo or etanercept (ReSurface 2 only); in part 2 the initial placebo and etanercept arms were re-randomized at week 12 to receive tildrakizumab 200mg and 100mg; and in part 3, after week 28, responders (Psoriasis Area Sensitivity Index [PASI] ≥75) and partial responders (PASI ≥50 to <75) were re-randomized again.
Ongoing results have showed that at week 12 an average of 37% and 36% in the 100mg and 200mg tildrakizumab arms achieved PASI 90. The percentages increased to 54% and 59% at week 28, respectively. These rates of PASI were higher than both the placebo and etanercept arms. Overall, 63% of patients receiving the 100mg dose achieved 75% skin clearance by week 12 after two injections. After week 28, 77% of this group achieved 75% skin clearance.
The trials are intended to examined safety and efficacy for five years. Further insights on trial data and primary endpoints will be released in future presentations and publications, say Sun Pharma.
For more information visit SunPharmaDerm.com.