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FDA advisory committee recommends approval of hyponatremia drug

The FDA advisory committee on cardiovascular and renal drugs voted to recommend the approval of tolvaptan, Otsuka Pharmaceutical Development & Commercialization's investigational treatment for patients with hyponatremia.

Otsuka’s 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.

Taro Iwamoto, CEO, president and COO of Otsuka Pharmaceutical Development & Commercialization, said: “Otsuka is pleased that the FDA advisory committee supports the potential approval of tolvaptan, an investigational selective V2-vasopressin receptor antagonist. We believe tolvaptan, if approved by the FDA, has the potential to be an important treatment option for people with hyponatremia.”