FDA approves Takeda's ARB, Edarbi

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The FDA has approved azilsartan medoxomil (Edarbi, Takeda Pharmaceutical Company Limited), a once-daily angiotensin II receptor blocker (ARB) indicated to treat hypertension or high blood pressure. The drug can be used alone or in combination with other antihypertensive therapies.

The company, which is a subsidiary of Takeda Pharmaceuticals North America, said that the new drug application (NDA) was submitted in April 2010 and was supported by seven controlled Phase III clinical trials that involved more than 5,900 patients with hypertension.

The Phase III trials showed that an 80 mg/day dose of Edarbi was statistically superior to placebo and two ARBs—olmesartan medoxomil (Benicar, Daiichi Sankyo) and valsartan (Diovan, Novartis)—in lowering both clinic and 24-hour mean blood pressure measurements.

The results of the trial showed that 80 mg/day and 40 mg/day doses of Edarbi lowered 24-hour mean systolic blood pressure by 14.3 mmHg and 13.2 mmHg, respectively, according to Osaka, Japan-based Takeda Pharmaceutical Company Limited.

The company said that small reversible increases in serum creatinine were seen when patients received 80 mg doses of the drug and may be larger when administered with chlorthalidone or hydrochlorothiazide. Patients older than age 75 were more likely to report serum creatinine increases.

The company said that renal function should be monitored in elderly patients who are receiving Edarbi or those who have compromised renal function due to the possibility of reversible deterioration of renal function. In addition, the drug should be avoided in pregnant patients due to its potential to cause the fetus harm or death.