Daiichi planning Japanese application for hypertension candidate

Daiichi Sankyo Co. Ltd. (Tokyo:4568) and Exelixis Inc. (NASDAQ:EXEL) said esaxerenone (CS-3150) met the primary endpoint in the Japanese Phase III ESAX-HTN trial to treat essential hypertension. In 1Q18, Daiichi plans to submit a regulatory application in Japan for the oral non-steroidal mineralocorticoid receptor antagonist in the indication. The company did not respond to an inquiry about whether it plans to seek approval via Japan’s Sakigake accelerated approval pathway (see BioCentury, April 20, 2015).

In the 1,001-patient trial, once-daily oral esaxerenone significantly improved sitting systolic and diastolic blood pressure from baseline to week 12 vs. Inspra eplerenone. Daiichi plans to report detailed results at upcoming scientific meetings...