EMA reviewing Otsuka's tolvaptan for ADPKD

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said EMA accepted for review an MAA for tolvaptan to treat autosomal dominant polycystic kidney disease (ADPKD), a rare genetic disease characterized by non-malignant cysts in the kidneys. The vasopressin 2 (V2) receptor antagonist, which is also under review in Japan for the indication, is approved in the EU to treat hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. ...