Otsuka's Samsca, first ADPKD therapy, approved in Japan

25 March 2014

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says it has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD).

The company announced that Samsca (tolvaptan) has been approved in Japan in 7.5mg and 15mg tablet forms for extended use for the additional indication of ADPKD. Also, the new dosage form of 30-mg Samsca tablets has received approval for the indication of ADPKD.

Samsca was developed over the past 26 years by Otsuka researchers and is currently used in 14 countries and territories around the world as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopressin V2 receptors.

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