The US Food and Drug Administration has approved Sun Pharma’s Ilumya as a new treatment option for adults with moderate-to-severe plaque psoriasis.
Ilumya (tildrakizumab-asmn) works by selectively binding to a subunit of IL-23, inhibiting its interaction with the IL-23 receptor, which leads to inhibition of the release of pro-inflammatory cytokines and chemokines.
Phase III data demonstrated significant clinical improvement with Ilumya 100mg compared to placebo when measured by at least 75 percent of skin clearance (PASI 75) and Physician's Global Assessment (PGA) score of "clear" or "minimal" at week 12 after two doses.
In the reSURFACE study, 74 percent achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomised to placebo.
In addition, 69 percent of the patients receiving Ilumya 100mg who had a PGA score of "clear" or "minimal" at week 28 maintained this response at week 64 compared to 14 percent of patients who were re-randomised to placebo, the firm noted.
The FDA’s approval allows physicians to prescribe the drug to patients who are candidates for systemic therapy or phototherapy.