May 13, 2019
Products

For Immediate Release

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and COO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Junichi Onuma,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
https://www.daiichisankyo.com

Daiichi Sankyo Launches “MINNEBRO® Tablets” in Japan

 

Tokyo, Japan (May 13, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the launch in Japan of MINNEBRO® Tablets 1.25 mg, 2.5 mg and 5 mg (generic name: esaxerenone; hereafter, the drug).

 

The drug is a novel, non-steroidal, selective mineralocorticoid receptor*1 blocker identified during the research collaboration with Exelixis, Inc. (based in Alameda, California, U.S.), and has subsequently been developed by Daiichi Sankyo independently. Marketing approval for the indication of hypertension was received in January, 2019, on the basis of the results of a domestic phase 3 clinical trial (ESAX-HTN study) in patients with essential hypertension*2.

 

Daiichi Sankyo expects the drug to benefit patients by providing a new therapeutic option for the treatment of hypertension.

 

 

Product outline

 

Brand name

MINNEBRO® Tablets 1.25 mg, 2.5 mg, 5 mg

Generic name (JAN)

Esaxerenone

Indication

Hypertension

Dosage and administration

The recommended oral dose of esaxerenone is 2.5 mg once daily. The dose for patients with an inadequate response can be increased up to 5 mg once daily.

Drug price

MINNEBRO® Tablets 1.25mg: 46.90 yen/tablet

MINNEBRO® Tablets 2.5mg: 89.90 yen/tablet

MINNEBRO® Tablets 5mg: 134.90 yen/tablet

Date of approval

for manufacturing and marketing

January 8, 2019

Date of listing in the NHI Price

February 26, 2019

Date of launch

May 13, 2019

Manufacture and Marketing

Daiichi Sankyo Company, Limited

 

*1 Mineralocorticoid receptor

The mineralocorticoid receptor is a receptor for steroid hormones that control the blood’s electrolyte balance. Excessive activation of mineralocorticoid receptors has been found to be involved in hypertension.

 

*2 Essential hypertension

Essential hypertension is the major form of hypertension accounting for 90% of hypertensive patients and is associated with heterogeneous factors like genetics and lifestyle habits, while secondary hypertension is the result of identified underlying disease factors.

 

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com