BRIEF—Phase III data will support Otsuka's FDA resubmission

Tokyo’s Otsuka Pharmaceutical has presented detailed data from the Phase III REPRISE trial of tolvaptan in patients with ADPKD, the autosomal dominant, most common form of polycystic kidney disease.

The firm says that data showed greater reduction on the primary endpoint, a key measure of kidney function, compared to placebo.

Otsuka’s 2013 regulatory filing was rebuffed by the US FDA. The firm has now resubmitted in the USA using data from the REPRISE and other trials.

The drug was approved for ADPKD under the brand name Jinarc in Europe in May 2015 and as Samsca in Japan in March 2014.