Marketing Authorisation Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatraemia, Accepted by The European Medicines Agency
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
Source: Otsuka Pharmaceutical Europe Ltd. (OPEL)
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
2008-02-26 19:06:15 0298963 PRNEWSWIRE