UXBRIDGE, England, February 27 /PRNewswire/ -- Otsuka Pharmaceutical Europe Ltd. (OPEL) announced today 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. (1) These indications are based on data from two separate clinical development programmes.(2),(3),(4)
Professor Faiez Zannad, Professor of Therapeutics and Cardiology, University Hospital Nancy, France and EVEREST Executive Steering Committee member commented regarding the acceptance of the MAA for tolvaptan by the EMEA: "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.
About Heart Failure
More than 14 million people in Europe(5) have heart failure, a serious chronic condition in which the heart cannot effectively pump blood, and 3.6 million people in Europe are diagnosed with heart failure every year.(6)
About Hyponatraemia
Hyponatraemia, characterised by low concentrations of sodium in the blood, is a known predictor of death in patients with serious underlying illnesses.(4) Hyponatraemia has long been associated with neurological symptoms including in its worst forms seizure and coma, and in its mildest forms slowed thoughts and reflexes.(7) Normal serum sodium is between 135 to 145 mEq/L, whereas patients diagnosed with hyponatraemia have sodium levels of less than 135 mEq/L.(8)
About Otsuka Pharmaceutical Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka - people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 17 countries and regions worldwide. For additional information, visit http://www.otsuka-europe.com.
1. Current Proposed PLR, October 19, 2007. Page 1. Supplied by Otsuka.
2. Gheorghiade M, Konstam MA, Burnett JC et al. Effects of Oral Tolvaptan in Patients Hospitalized for Worsening Heart Failure. The EVEREST Outcome Trial. JAMA. 2007; 297(12):1319-1331
3. Gheorghiade M, Konstam MA, Burnett JC et al. Short-term Clinical Effects of Tolvaptan, an Oral Vasopressin Antagonist, in Patients Hospitalized for Heart Failure. The EVEREST Clinical Trial Status. JAMA. 2007; 297(12):1332-1343
4. Schrier RW, Gross P, Gheorghiade M et al. Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist, for Hyponatremia. (SALT-1, SALT-2). NEJM. 2006; 355(20):2099-112
5. SHAPE Survey Results to the General Public, Annual Congress of the European Society of Cardiology in Vienna, September 2003
6. http://www.heartfailurematters.org accessed 26 February 2008
7. Adrogue HJ and Madias NE. Hyponatremia. NEJM. 2000; 342 (21):1581-1589
8. Gheorghiade M, Gottlieb SS, Udelson JE et al. Vasopressin V2 Receptor Blockade with Tolvaptan versus Fluid Restriction in the Treatment of Hyponatraemia. Am J Cardiol 2006; 97:1064-1067
Contact: Ali Ross, Otsuka Pharmaceutical Europe Ltd., Tel: +44(0)7768-337128, aross@otsuka-europe.com; Kim Lawden, Huntsworth Health, Tel: +44(0)1628-480-468, kimlawden@hhealth.com
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