FDA accepts Otsuka’s NDA for tolvaptan

The new drug application (NDA) has been submitted for two indications, treatment of adults with worsening heart failure and treatment of hyponatremia. These indications are based on data from three Phase III pivotal trials.

Tolvaptan is a novel, investigational small molecule designed to be an antagonist of the vasopressin V2 receptor, which plays a role in the kidney’s regulation of fluid excretion. The majority of patients hospitalized for worsening heart failure have edema or excess body fluid, which is treated with diuretics to excrete the fluid. In contrast to diuretics, tolvaptan is designed to promote aquaresis, the excretion of electrolyte-free water.