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Daiichi Sankyo gets Japanese approval for hypertension drug

Daiichi Sankyo Co. Ltd. received marketing approval from the Japanese Ministry of Health, Labor and Welfare to use Minnebro tablets in treating hypertension.

Minnebro, also known as esaxerenone, is a compound identified in a research partnership between Tokyo-based Daiichi Sankyo and California-based Exelixis Inc.

Daiichi Sankyo will pay Exelixis a $20 million milestone fee upon the first commercial sale of Minnebro in Japan. Previously, Exelixis received the same amount following submission of the therapy's regulatory application.

Exelixis could receive substantial commercialization milestones, as well as low double-digit royalties on sales of the medicine.

The Japanese approval was based on phase 3 clinical trials, including a study dubbed ESAX-HTN, in which hypertension patients who received Minnebro exhibited lower blood pressure — the trial's main goal. Daiichi Sankyo is also evaluating Minnebro's effectiveness in Japanese patients with diabetic nephropathy, or kidney damage resulting from diabetes, in an ongoing late-stage study.