FDA Accepts NDA For Otsuka’s Novel Hyponatremia Treatment
FDA has accepted Otsuka’s new drug application for the investigational V2-vasopressin receptor antagonist tolvaptan, which could enter an increasingly crowded market.
Otsuka is seeking approval for two indications for the drug: treatment of adults with worsening heart failure and treatment of hyponatremia.
Astellas Pharma’s vasopressin receptor antagonist Vaprisol (conivaptan) is currently the only approved treatment for hospitalized patients with both hypervolemic hyponatremia and euvolemic hyponatremia (PharmAsia News, March 05, 2007).
Biogen Idec and Cardiokine are partnering on the selective V2 vasopressin receptor antagonist lixivaptan. Biogen Idec told PharmAsia News they expect to initiate Phase III trials in the first half of 2008.
Similar to Biogen’s strategy, Otsuka will likely try to distinguish itself from Vaprisol, which is intravenous, by touting its oral formulation. Otsuka told PharmAsia News it was unable to discuss competition because of the early stage of its NDA submission.
Otsuka submitted the NDA Oct. 24 based on data from three Phase III pivitol trials: SALT-1 and SALT 2 [Sodium Assessment With Increasing Levels of Tolvaptan in Hyponatremia] and EVEREST [Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan]. EVEREST data results earlier this year showed significantly improved signs and symptoms of acutely decompensated heart failure compared to placebo in the short-term trials, but tolvaptan did not reduce mortality or heart-failure-related morbidity in the long-term outcomes.
In contrast to diuretics used to treat edema related to worsening heart failure, tolvaptan is designed to promote aquaresis, the excretion of electrolyte-free water. Roughly 1 million patients hospitalized for worsening heart failure have edema or excess body fluid.
Otsuka told PharmAsia News it is seeking a standard review, and based on the acceptance letter, the PDUFA first action date is Aug. 23, 2008.
– Daniel Poppy (d.poppy@elsevier.com)
© FDC Reports 2007 - All Rights Reserved
