FDA advisory committee recommends approval of Tolvaptan for hyponatremia

Jun 25 2008

The U.S. Food and Drug Administration (FDA) Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Otsuka Pharmaceutical Development & Commercialization, Inc.'s (OPDC) investigational treatment for patients with hyponatremia.

"Otsuka is pleased that the FDA Advisory Committee supports the potential approval of tolvaptan, an investigational selective V2-vasopressin receptor antagonist," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer of OPDC. "We believe tolvaptan, if approved by the FDA, has the potential to be an important treatment option for people with hyponatremia."

Hyponatremia, characterized by low concentrations of sodium in the blood, is a known predictor of mortality in patients with serious underlying illnesses. Sodium is an important electrolyte that plays a role in blood pressure maintenance, muscle movement, and fluid regulation in and around cells. Approximately 3.2 million to 6.1 million people in the U.S. suffer from hyponatremia annually.

Tolvaptan is an investigational selective antagonist of the vasopressin V2 receptor, which is located predominantly in the kidney and plays a role in the regulation of fluid retention in the body. Vasopressin V2 antagonists work by selectively blocking the V2 receptor. This mechanism of action hinders water reabsorption and results in increased free water excretion (aquaresis), which is characterized by increased urine volume with no increase in urinary electrolyte excretion.

OPDC was established in 2007 by Otsuka America, Inc. (OAI). OPDC is wholly owned by OAI, which is the holding company for Otsuka Pharmaceutical Co., Ltd. (OPC) interests in the U.S. OAI is wholly owned by OPC.