US FDA accepts NDAs for Otsuka's tolvaptan and BTG's Varisolve

Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration has accepted for priority review the company’s New Drug Application for the potential use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The drug is already approved for the treatment of hyponatremia.

If approved by 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, says Otsuka. ADPKD is a hereditary genetic illness characterized by the development of multiple cysts in the kidneys. ADPKD is the most common inherited kidney disease and the fourth most common overall cause of kidney failure worldwide, with the diagnosed prevalence estimated to be between 1:1,000 and 1:4,000 globally.

Tolvaptan is a selective V2 vasopressin receptor antagonist that has been hypothesized to slow the progression of ADPKD by reducing the development and growth of kidney cysts, which are characteristic of the disease and often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.