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news.Takeda Pharmaceutical Company has announced that the Japanese Ministry of Health, Labour and Welfare has approved its new drug application for Ecard, a fixed dose combination tablet of Blopress and a low-dose diuretic for treatment of hypertension.
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Ecard is a tablet taken orally once daily and the two approved formulations are ‘Ecard LD’ and ‘Ecard HD’; 4mg candesartan cilexetil/6.25mg hydrochlorothiazide and 8mg candesartan cilexetil/6.25mg hydrochlorothiazide, respectively.
By reducing the hydrochlorothiazide dose to 6.25mg, which is a quarter of the ordinary clinical dosage, it is believed that commonly-experienced adverse events of thiazide diuretics can be lessened. An enhancement in anti hypertensive effect was also demonstrated in the Phase III clinical trial, the company said.
Masaomi Miyamoto, general manager of pharmaceutical development division at Takeda, said: “We believe that the fixed dose combination tablet of Blopress with a diuretic will be able to offer better control of blood pressure to patients with hypertension. We also expect that this product approval will further maximize the value of Blopress and enhance our hypertension franchise in Japanese market.”