Sun Pharmaceutical Industries, on Tuesday, announced that its new drug application (NDA) of tildrakizumab injection used for treatment of adults with moderate-to-severe plaque psoriasis approved by the Chinese health authority.
In a regulatory filing, the company said, “The product under the brand name Ilumetri has been approved by China's National Medical Products Administration (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.
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, the company said in a BSE filing.
Ilumetri is a humanised, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this precise targeting, ILUMETRI has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system.