Daiichi Sankyo Co. Ltd. submitted a new drug application for esaxerenone to the Japanese Pharmaceutical and Medical Devices Agency.
The Tokyo-based drugmaker said it expects the drug to provide a new option to treat hypertension. The application is based on phase 3 trial data for the drug, which was evaluated in patients with essential hypertension.
An estimated 43 million people over 30 years old in Japan have hypertension, according to the Japan National Health and Nutrition Survey 2012. Essential hypertension accounts for 90% of hypertensive patients.
Separately, San Francisco-based Exelixis Inc., which helped develop esaxerenone, said the regulatory application triggered a $20 million milestone payment from Daiichi Sankyo.