EMEA accepts Otsuka's tolvaptan MAA

Otsuka Pharmaceutical Europe, part of the Japanese Otsuka group, says that the European Medicines Agency (EMEA) has accepted a Marketing Authorization Application for its investigational oral once-daily medication tolvaptan, a selective V2-vasopressin receptor antagonist, for the treatment of worsening heart failure and the treatment of hyponatremia. These indications are based on data from two separate clinical development programs.

Faiez Zannad, professor of therapeutics and cardiology at the University Hospital Nancy, France, and EVEREST executive steering committee member commented regarding the acceptance of the MAA that "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 program showed that once-daily oral tolvaptan improved the signs and symptoms of worsening heart failure in hospitalized patients.