Mumbai-based Sun Pharma has just received Food and Drug Administration (FDA) approval for ILUMYA (tildrakizumab-asmn), a medication that reduces redness in adult patients with moderate to severe plaque psoriasis who qualify for systemic therapy or phototherapy.
The approval comes on the heels of data published from a Phase-3 reSURFACE clinical development program. In the double-blind study published in The Lancet, 926 adult patients received ILUMYA or placebo. The research demonstrated that participants in the first trial who used ILUMYA experienced “at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index of PASI 75)”. They also received both “clear” and “minimal” Physicians Global Assessment scores at the week 12 mark after two doses.
ILUMYA prevents the release of pro-inflammatory cytokines and chemokines by binding to the p19 subunit of IL-23 and thus hindering its interaction with IL-23 receptor. Patients start off by taking one preliminary dose through subcutaneous injection and another dose four weeks later. Subsequent doses of 100 mg are administered once every three months.
"With the approval of ILUMYA and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis," said Abhay Gandhip, President and Chief Executive Officer of Sun Pharma’s North America division, in a release. "We are committed to working with all relevant stakeholders to make ILUMYA available to appropriate people with plaque psoriasis."