Sun Pharmaceutical Industries announced that the New Drug Application (NDA) for tildrakizumab injection under the brand name ILUMETRI has been approved by the National Medical Products Administration of the People’s Republic of China (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In June 2019, Sun Pharma out-licensed tildrakizumab to a subsidiary of China Medical System Holdings Limited (CMS), for development, regulatory filings and commercialisation of the product in Greater China. According to CMS, the results of the extended study of Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over the treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3 per cent at week 52, and ILUMETRI showed good long-term safety and tolerance.
Tildrakizumab Injection has also been approved for marketing in the US, EU, Japan, UK, Switzerland, Canada, Australia, Hong Kong and other countries/regions under the brands of ILUMYA and ILUMETRI in different geographies.