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12 Apr 2013

FDA to review NDA for the treatment of autosomal dominant polycystic kidney...

Tolvaptan is being reviewed as a potential treatment for ADPKD.

The US Food and Drug Administration (FDA) has accepted for review Otsuka Pharmaceutical's new drug application (NDA) of treatment for patients with autosomal dominant polycystic kidney disease (ADPKD).
Tolvaptan, a selective V2 vasopressin receptor antagonist, has the potential to be used as a treatment for ADPKD after being shown to slow its progression by reducing the growth of kidney cysts.
Phase III clinical trial results that form the basis of the regulatory filing were published online in the New England Journal of Medicine, according to a statement from the Japanese pharmaceutical company.
Kidney cysts are characteristic of ADPKD and have been linked with pain hypertension, reduced kidney function and kidney failure.
President and representative director of Otsuka Pharmaceutical Dr Taro Iwamoto explained that the submission of the NDA represented a significant "milestone" for the company and patients with the disease.
"Tolvaptan was discovered by Otsuka in Japan and if approved by the FDA would become the first pharmaceutical therapy for patients who suffer from ADPKD," he added.

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