The FINANCIAL — Takeda Pharmaceutical Company Limited (“Takeda”) announced on March 30 that it submitted a New Drug Application to the Ministry of Health, Labour and Welfare for a fixed dose combination of Blopress (generic name: candesartan cilexetil) and amlodipine besylate for treatment of hypertension.
Discovered by Takeda, Blopress is an angiotensin receptor blocker (ARB) which inhibits action of a vasopressor hormone, Angiotensin II. In Japan, it was launched in 1999 and was the first ARB to obtain an additional indication for chronic heart failure in 2005. Amlodipine besylate is a calcium channel blocker (CCB), having a hypotensive action by blocking inward calcium ion channels mainly in vascular smooth-muscle cells, resulting peripheral arteriolar vasodilation.
In the guideline 2009 issued by The Japanese Society of Hypertension, the combination therapy of anti-hypertensive treatments, in case monotherapy does not show enough efficacy, is recommended, and the combination of ARB and CCB is one of such treatments in that guideline, being a logical one from the viewpoints of safety and efficacy, without affecting the efficacy of each medicine.
If approved, Takeda expects that the combination of Blopress and amlodipine besylate, most prescribed ARB and CCB respectively in Japan, can offer a new treatment option for those who are currently taking both medicines and also those who are taking either one of two medicines as monotherapy but needing additional treatment. In addition, this combination product is expected to improve the ratio of patients with hypertension attaining the target blood pressure level, administration compliance of patients based on a reduced number of tables to take, as a suitable product for long-term control of blood pressure.
This fixed dose combination product of Blopress and amlodipine besylate represents Takeda’s continued initiative to contribute to convenience for patients through offering treatment options with formulations suitable for pathologic conditions of individual patients, Takeda just launched ECARD LD and ECARD HD, which are combination tablets of Blopress with diuretic, in Japan on 13th of this month.