Thursday, 28 January 2021

Sun Pharma announces regulatory filing of Tildrakizumab in Japan

01 August 2019 | News

Filing is a significant milestone in establishing the specialty business in Japan and adds one more potential market for Tildrakizumab globally

Sun Pharmaceutical Industries Ltd. has 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.

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