Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Otsuka Pharmaceutical Co., Ltd. has filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine in November 2012. In the Phase 3 trials,  involving 1,400 ADPKD patients from 15 countries, Tolvaptan demonstrated a statistically significant reduction in the rate of total kidney volume. The MHLW has designated tolvaptan as an Orphan Drug.

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