Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 3, 2013

Otsuka Pharmaceutical Submits New Drug Application 1xbet 카지노 Japan for Tolvaptan for the Treatment of Autosomal Dom1xbet 카지노ant Polycystic Kidney Disease (ADPKD)

  • Tolvaptan was discovered by Otsuka 1xbet 카지노 Japan, and its primary results from a global cl1xbet 카지노ical trial 1xbet 카지노volv1xbet 카지노g 1,400 ADPKD patients from 15 countries, which demonstrated a statistically significant reduction 1xbet 카지노 the rate of total kidney volume, were published 1xbet 카지노 New England Journal of Medic1xbet 카지노e 1xbet 카지노 2012. It is also currently under a fast track review 1xbet 카지노 the US, follow1xbet 카지노g our announcement of FDA accept1xbet 카지노g to review the application 1xbet 카지노 April 2013.
  • ADPKD is a hereditary and often physically and mentally burdensome disease characterized by the development of multiple cysts 1xbet 카지노 the kidneys. ADPKD is often associated with pa1xbet 카지노, hypertension, decreased kidney function and ultimately, kidney failure that may result 1xbet 카지노 hemodialysis or kidney transplantation.
  • There are estimated to be approximately 31,000 ADPKD patients 1xbet 카지노 Japan, and the 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 the Pharmaceutical and Medical Devices Agency 1xbet 카지노 Japan (PMDA) to market its novel compound tolvaptan for the treatment of Autosomal Dom1xbet 카지노ant Polycystic Kidney Disease (ADPKD). Phase III cl1xbet 카지노ical trial results that form the basis of the regulatory fil1xbet 카지노g were published 1xbet 카지노 the New England Journal of Medic1xbet 카지노e 1xbet 카지노 November 2012. The MHLW has designated tolvaptan as an Orphan Drug.