Otsuka's Samsca gains additional indication in Japan

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan) has been granted an additional indication in Japan for the treatment of fluid retention in patients with hepatic cirrhosis.

Aquaretic agent Samsca was approved in Japan for the treatment of volume overload in patients with liver cirrhosis. Approval of this new indication in Japan is the first such approval in the world, offering a new treatment option to hepatic cirrhosis patients experiencing difficulties or inadequacy with conventional diuretic treatments.

Just last month, a US Food and Drug Administration advisory panel voted nine to six not to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD; The Pharma Letter August 6). Tolvaptan was approved by the FDA in 2009 for the treatment of hyponatremia (low blood sodium levels).