Otsuka Pharmaceuticals receives MAA approval for kidney disease drug

Otsuka Pharmaceuticals has confirmed its marketing authorisation application (MAA) for the potential approval of kidney disease drug tolvaptan has been accepted by the European Medicines Agency (EMA).

This follows the phase III clinical trial results, which formed the basis of the filing and were published in the New England Journal of Medicine.

Tolvaptan is a selective antagonist that targets the V2 vasopressin receptor and reduces the development and growth of kidney cysts, slowing the progression of autosomal dominant polycystic kidney disease (ADPKD).

Ole Vahlgren, chief executive and president of Otsuka Europe, said: "Otsuka is delighted that the EMA will review the tolvaptan MAA for the treatment of ADPKD based on compelling data from our pivotal three-year phase III clinical trial."

The disease is a hereditary genetic condition and leads to slow deterioration of kidney function. In approximately half of cases, it leads to end-stage renal disease and renal failure. There are currently no licensed treatments available.