Sun Pharma gets Chinese nod for plaque psoriasis injection Tildrakizumab

Mumbai: Sun Pharmaceutical Industries Limited has announced that the New Drug Application (NDA) of tildrakizumab injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of the People’s Republic of China (“China”) (NMPA).

ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is a humanized, 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.

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 treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% 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.

Psoriasis is a chronic immune disease that appears on the skin. It affects approximately 125 million people worldwide. It is a noncontagious disorder that accelerates the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite different treatment options existing, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.

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