FDA Agrees to Priority Review for First ADPKD Therapy

Otsuka announced that the FDA has accepted its New Drug Application (NDA) for priority review for the potential use of tolvaptan in the treatment of autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan (Samsca) is a selective vasopressin V2-receptor antagonist that has been hypothesized to slow the progression of ADPKD by reducing the development and growth of kidney cysts. These kidney cysts are characteristic of the disease and are often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.

If approved by the FDA, tolvaptan would become the first pharmaceutical therapy for patients with ADPKD, an inherited genetic disease for which there is no current pharmaceutical treatment option.

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