Sun Pharmaceutical Industries Ltd. announced the launch of its global innovative drug, ILUMYA (Tildrakizumab) in India for moderate-to-severe plaque psoriasis. A novel biologic treatment, ILUMYA has been endorsed widely by dermatologists in the US and worldwide for several years as an effective and safe treatment of moderate to severe plaque psoriasis.
“ILUMYA offers a safe and effective treatment option for patients who are struggling to manage their moderate-to- severe plaque psoriasis,” said Kirti Ganorkar, Managing Director, Sun Pharma. “We are pleased to introduce this novel therapy in India from our global portfolio of innovative medicines. Already available in 35 countries, ILUMYA has consistently demonstrated significant and long-lasting skin clearance, beginning soon after initiation and sustained over years.”
Sun Pharma’s clinical study in India included 115 patients of moderate-to-severe plaque psoriasis. A 75 percent skin clearance (≥75% reduction in Psoriasis Area Severity Index Score) was seen in 62.3%, 83.3% and 93.9% patients, respectively at Weeks 12, 16, 28. A 90 percent skin clearance (≥90% reduction in Psoriasis Area Severity Index Score) was seen in 26.3%, 50%, & 78.1% patients, respectively at Week 12, 16 & 28. Patients received 3 subcutaneous injections of Tildrakizumab over a period of 16 Weeks (Day 1, Week 4 & Week 16) and were followed for a period of 28 weeks. Significant improvements were also observed on additional efficacy endpoints such as, Dermatology Life Quality Index (DLQI) score. Tildrakizumab was well tolerated by Indian patients, with no immunogenicity concerns observed in this study.
“Having been involved in the clinical development of Tildrakizumab in India, I am pleased to see its potential as an effective, safe, and long-lasting treatment for psoriasis. In the Phase-3 trial, tildrakizumab demonstrated significant improvements across all measures, with approximately 93.5% reduction in PASI score and pronounced skin clearance.” said Dr. B. S. Chandrashekar, Chief Dermatologist and Managing Director at Cutis Academy of Cutaneous Sciences, Bengaluru, India who was also an investigator in India Phase 3 trial. “These results showcase its benefits in improving the quality of life for psoriasis patients.”
ILUMYA is the first IL-23 inhibitor to complete five years of study based on a pooled analysis of two Phase 3 efficacy and safety extension trials in moderate-to-severe plaque psoriasis9. Patients living with moderate-to-severe plaque psoriasis need therapies they can use over long periods of time without loss of efficacy, and data shows that ILUMYA is a sustainable choice for patients over the long term.
About ILUMYA®
ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYATM is indicated for the treatment of adults with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The U.S. Food and Drug Administration approval is based on data from the pivotal Phase-3 reSURFACE clinical development program, which consisted of two randomized, double-blind, placebo-controlled trials of more than 1,800 patients across over 200 clinical trial sites.
