NICE recommends Samsca (tolvaptan), from Otsuka, be made available for treating autosomal dominant polycystic kidney disease (ADPKD) in adults with...
Tolvaptan Teva is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (see section 5.1).
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
The vasopressin V2 receptor antagonist tolvaptan delays the progression of autosomal dominant polycystic kidney disease (ADPKD). However, some patients discontinue tolvaptan because of severe adverse aquaretic events.
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
The Cardiovascular and Renal Drugs Advisory Committee of the FDA has voted 9 to 6 not to approve Samsca (tolvaptan)...