Sun Pharma Receives European Commission Approval for ILUMETRI
Deepthi | Myequity news | Date : 18-09-2018 17:30:00 IST
Sun Pharmaceutical Industries Ltd. announced that Almirall has received the European Commission (EC) approval for ILUMETRI® (tildrakizumab) for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy. As indicated by Almirall, roll out of ILUMETRI® in Europe will start in the next few weeks. In July 2016, Sun Pharma out-licensed tildrakizumab to Almirall, for the development and commercialization of the product for psoriasis in Europe.
Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody. Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system.
Its approval in Europe is based on the positive results from resurface 1 and 2 phase-3 clinical trials3, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress in Vienna (Austria). Both pivotal phase-3 clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed ILUMETRI® has a high level of safety and efficacy.
According to both studies data, an average of 63% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 78% at week 28. Moreover, an average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28. Over a year, more than 92% of patients who responded to ILUMETRI® within 28 weeks maintained a PASI 75 response.
Moreover, the results of a pooled analysis through three years2 from resurface 1 and 2 phase- 3 trials show the consistent maintenance of efficacy and safety over three years of ILUMETRI® in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with ILUMETRI® in 90% of patients up to week 148. ILUMETRI® was well-tolerated with very low drug-related serious adverse events and discontinuation rates. About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement:
Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary licensed worldwide rights to Tildrakizumab from a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in 2014. Funded by a Sun Pharma subsidiary, Merck & Co., Inc., Kenilworth, NJ, USA is responsible for the completion of Phase-3 trials in patients with moderate-to-severe plaque psoriasis and submission of a Biologics License Application to the United States Food and Drug
Administration (FDA), as well as manufacturing finished goods to support Sun Pharma’s initial product launch. Sun Pharma will be responsible for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck & Co., Inc., Kenilworth, NJ, USA is eligible to receive milestone payments and royalties on sales of Tildrakizumab.