Takeda Pharmaceutical Korea said Tuesday it got approval for its antihypertensive drug Edarbyclor (azilsartan medoxomil/chlorthalidone), with its monotherapy Edarbi (azilsartan medoxomil) proving efficacy over valsartan-containing hypertension drugs in clinical trials.
The Ministry of Food and Drug Safety’s approval was based on a randomized, double-blind, phase 3 study on 1,071 stage-2 hypertensive patients with systolic blood pressure between 160mmHg and 190mmHg, proving the safety and efficacy profile of the drug.
Takeda’s Edarbyclor is an Angiotensin II Receptor Blockers (ARB) class medication that combines Edarbi (azilsartan medoxomil) and a thiazide diuretic, chlorthalidone. Edarbi blocks the action of angiotensin II, the body's blood pressure-increasing hormone, and dilates blood vessels to reduce blood pressure. Chlorthalidone increases the amount of urination and reduces water content in the body.
“Monotherapies are often insufficient to control blood pressure for hypertension patients. Combination therapies for the early treatment of stage-2 patients with hypertension whose systolic blood pressure exceed 160 mmHg, and diastolic blood pressure surpasses 100 mmHg is necessary,” said Professor Kang Hyun-jae from Seoul National University Hospital, Department of Cardiology.
“Edarbyclor is acting as long as Edarbi, which has shown superior effects among ARB class drugs, and have proved cardiovascular efficacy and safety profile through various studies, making the chlorthalidone combination therapy recommended by several guidelines by showing superior treatment effects for hypertension patients whose blood pressure is not controlled easily,” the professor added.
In previous clinical trials, chlortalidone proved effectiveness in reducing blood pressure in hypertensive patients and significant reduction of hypertensive complications upon long-term use. In particular, Edarbi showed efficacy over valsartan-containing hypertension drug Diovan in previous studies, a company official noted.
“Although both drugs are ARB-class drugs and have a similar blocking mechanism, they have completely different active ingredients and different manufacturing method. Although Edarbyclor was launched later than Edarbi, uptake in hospitals has been great so far,” a Takeda official said.
Adults can take Edarbyclor once a day, regardless of diet, with the recommended dose being 40 / 12.5 mg daily.
Last month, the Ministry of Food and Drug Safety recalled 115 antihypertension drugs produced by 54 companies containing the active ingredient valsartan manufactured by China’s Zhejiang Huahai. The government further suspended manufacturing and sales of 59 medications made in Korea Monday.
Hypertension affects about one billion people worldwide, and the number is expected to increase to 1.5 billion people by 2025. Despite the increasing number of hypertensive patients and the emergence of various hypertension medicines, blood pressure control rate has stood at only 71 percent in hypertensive adults over 30 years of age.