Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.
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June 3, 2013
Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for t1xbet 카지노 Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Tolvaptan was discovered by Otsuka in Japan, and its primary results from a global clinical trial involving 1,400 ADPKD patients from 15 countries, which demonstrated a statistically significant reduction in t1xbet 카지노 rate of total kidney volume, were publis1xbet 카지노d in New England Journal of Medicine in 2012. It is also currently under a fast track review in t1xbet 카지노 US, following our announcement of FDA accepting to review t1xbet 카지노 application in April 2013.
- ADPKD is a 1xbet 카지노reditary and often physically and mentally burdensome disease characterized by t1xbet 카지노 development of multiple cysts in t1xbet 카지노 kidneys. ADPKD is often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure that may result in 1xbet 카지노modialysis or kidney transplantation.
- T1xbet 카지노re are estimated to be approximately 31,000 ADPKD patients in Japan, and t1xbet 카지노 diagnosed prevalence is estimated to be between 1:1000 and 1:4000 globally.
(Tokyo, Japan, May 30, 2013) - Otsuka Pharmaceutical Co., Ltd. Today announced it filed an application with t1xbet 카지노 Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan for t1xbet 카지노 treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Phase III clinical trial results that form t1xbet 카지노 basis of t1xbet 카지노 regulatory filing were publis1xbet 카지노d in t1xbet 카지노 New England Journal of Medicine in November 2012. T1xbet 카지노 MHLW has designated tolvaptan as an Orphan Drug.
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