First three-part tablets approved by Japanese regulators for treatment of hypertension
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Daiichi Sankyo, a Japanese pharmaceutical company, announced that 1.25mg, 2.5mg and 5mg tablets of the esaxerenone had been approved by Japanese regulators to treat high blood pressureMinnebro was one of the compounds found in a research collaboration between(http://(http://, a u.SPharmaceutical(http://)company, in March 2006, which was subsequently developed by First III and submitted aapplication for theNew Drug(http:// in Japan in February 2018the approval of theMinnebro is based on the results of Phase III clinical studies, including ESAX-HTNThe ESAX-HTN study, a randomized, double-blind, three-arm parallel group comparison study, was conducted in 1001 Japanese primary hypertension patients to assess the efficacy and safety of Minnebro relative to eprerenone, with the study focusing on changes in the relative baseline of sit-in sylland pressure (SBP)/diastolic pressure after 12 weeksdata showed that after 12 weeks of treatment, the Minnebro treatment group showed a significant improvement in the relative baseline of sit-in systolic systolic pressure (SBP)/diastolic pressure, reaching the main endpoint of the studyunder the cooperation agreement between the two parties, the first three have paid Exelixis a $20 million milestone when submitting the application for a new drug in Minnebro, and a total of $20 million in milestone payments when Minnebro was approved in Japan and commercialized sales were initiated Exelixis will also be eligible for the agreed sales milestones, as well as a two-digit royalty on Minnebro sales Since the end of the joint research period in November 2007, First III has been responsible for all subsequent clinical and clinical development and for the regulatory, manufacturing and commercialization of Minnebro , another critical Phase III clinical study (ESAX-DN) is being conducted to evaluate the efficacy and safety of Minnebro in the treatment of patients with diabetic nephropathy in Japan
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