Otsuka gains FDA approval for kidney disease drug

The US Food and Drug Administration has approved Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Japanese drugmaker Otsuka’s (TYO: 4578) is the first Jynarque drug to slow kidney decline in patients with the most common inherited kidney disease to be approved by the FDA.

The FDA rejected it in 2013 but approved it after the drugmaker did an additional study. That one-year study, involving 1,370 patients with advanced disease, found the drug on average slowed kidney function decline about 35 percent more than placebo.