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  5. Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD), an Orphan Disease

May 23, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD), an Orphan Disease

  • Samsca Tablets were approved in Japan on March 24, 2014 as the first therapeutic medication in the world for autosomal dominant polycystic kidney disease (ADPKD). Otsuka Pharmaceutical is launching an additional tablet formulation, "Samsca 30 mg Tablets," that will reduce the number of tablets patients with ADPKD need to take.
  • ADPKD is a genetic disease that results in the development of numerous cysts and enlargement of the kidneys. Patients are treated primarily by specialists in the fields of nephrology and urology. Otsuka has initiated e-Learning courses for specialist physicians in Japan, an essential program for them to understand the appropriate use of Samsca as drug therapy for ADPKD.
  • The number of specialists in Japan who are able to prescribe Samsca for ADPKD is still limited and patients are keen to see an increase in the number of such specialists. Approximately 700 physicians have taken the e-Learning course, and specialist prescribing of Samsca for ADPKD is gradually increasing. Otsuka will continue to provide information on ADPKD and information about the safety of Samsca.

On May 29, 2014, Otsuka Pharmaceutical Co., Ltd. will launch "Samsca 30 mg Tablets" (nonproprietary name: tolvaptan) as a new formulation, joining the existing 7.5 mg and 15 mg tablet formulations already available in Japan, for the indication "prevention of the progression of autosomal dominant polycystic kidney disease accompanied by an already enlarged renal volume and a high rate of increase in renal volume." Although this new indication has already been approved (as of March 24, 2014) and the existing 7.5 mg and 15 mg tablet formulations are already being prescribed for this indication, Otsuka is launching this new, high-strength 30 mg tablet formulation in order to improve patient convenience by reducing the number of tablets patients need to take.


Information in this news release was current as of the original release date.

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