Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries has filed an application for Manufacturing and Marketing Authorization of Tildrakizumab for moderate-to-severe psoriasis and psoriatic arthritis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
Kirti Ganorkar, EVP & Head Global Business Development, Sun Pharma said, “Sun Pharma is committed to growing its global dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. This filing in Japan is a step forward for Sun Pharma in expanding the global franchise for the product. It offers a potential new treatment option to patients who struggle everyday with the chronic nature of these aliments.”
The recent acquisition of Pola Pharma (Pola) in Japan will help Sun Pharma leverage Pola’s strong presence in the dermatology segment to commercialize Tildrakizumab post regulatory approval. Sun Pharma had announced the closure of the Pola acquisition in January 2019.
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. It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name.
It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The US FDA approval was 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.
Results from the Phase-3 reSURFACE 1 and 2 studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.
Both Phase-3 studies met the primary efficacy endpoints, with an average of 63 percent of patients receiving Tildrakizumab 100 mg achieving 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12, and 77 percent of patients achieving 75 percent skin clearance after 28 weeks (64 percent and 80 percent in reSURFACE 1, 61 percent and 74 percent in reSURFACE 2). Similarly, an average of 57 percent and 66 percent of patients receiving Tildrakizumab 100 mg had a Physician’s Global Assessment (PGA) score of “clear” or “minimal” at weeks 12 and 28, respectively. Additionally, a higher number of Tildrakizumab-treated patients achieved PASI 90 and PASI 100 compared to placebo and etanercept.
Tildrakizumab has also been approved and commercialized in Australia under the ILUMYATM brand name and in Europe under the ILUMETRITM brand name.