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Otsuka Pharma's Samsca Approved In Japan For Kidney Disease, ADPKD - Quick Facts

Otsuka Pharmaceutical Co. Ltd. announced that Samsca (generic name: tolvaptan) has been approved in Japan in 7.5-mg and 15-mg 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 autosomal dominant polycystic kidney disease or ADPKD.

Samsca was developed over the past 26 years by many researchers in Otsuka's Tokushima, Japan research facility. It 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.

ADPKD is a genetic disease in which the kidneys become enlarged due to proliferation of fluid-filled cysts. As the disease progresses renal function declines and complications ensue, including hypertension, hematuria and abdominal pain. The decline in renal function is such that by 70 years of age one half of those afflicted with ADPKD reach end-stage renal failure, with quality of life compromised and a burdensome prognosis.

In Europe, as of December, 2013, an application for regulatory approval of tolvaptan in ADPKD had been received and is under review. In the United States, based on a review issued by the FDA, the company has continued discussions with them regarding supplementary data and the path forward for resubmission.

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