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Published on 27 February 2008

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EMEA accepts Tolvaptan marketing authorisation application


Otsuka Pharmaceutical Europe Ltd (OPEL) has announced that the European Medicines Agency (EMEA) has accepted a marketing authorisation application (MAA) for the company’s investigational oral once-daily medication tolvaptan, a selective V2-vasopressin receptor antagonist, for the treatment of worsening heart failure and the treatment of hyponatraemia.

These indications are based on data from two separate clinical development programmes.

Professor Faiez Zannad, Professor of Therapeutics and Cardiology, University Hospital Nancy, France and EVEREST Executive Steering Committee member said:

“This is excellent news as tolvaptan represents the first major breakthrough in worsening heart failure in years. Heart failure is a serious and disabling condition and tolvaptan could alleviate distressing symptoms in these patients.”

Results from the EVEREST (Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan) trial programme showed that once-daily oral tolvaptan improved the signs and symptoms of worsening heart failure in hospitalised patients.

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 hospitalised for worsening heart failure have oedema or excess body fluid, which is treated with diuretics to excrete the fluid. In contrast to diuretics, tolvaptan is designed to promote the excretion of electrolyte-free water.


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