FDA panel gives nod to Otsuka's tolvaptan

The US Food and Drug Administration Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Japanese drugmaker Otsuka's investigational treatment for hyponatremia.

Characterized by low concentrations of sodium in the blood, hyponatremia 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 USA suffer from the condition each year.

Earlier this year (Marketletter March 3), the European Medicines Agency (EMEA) accepted Otsuka's Marketing Authorization Application for tolvaptan in the treatment of worsening heart failure as well as hyponatremia.