![EDARBI (azilsartan medoxomil) 40mg and 80mg tablets by Takeda Pharmaceuticals North America EDARBI (azilsartan medoxomil) 40mg and 80mg tablets by Takeda Pharmaceuticals North America](http://media.empr.com/images/2011/03/07/edarbi_40mg_80mg_150127_150128.jpg)
Edarbi (azilsartan medoxomil tablets; Takeda Pharmaceuticals North America) has been approved by the FDA for the treatment of hypertension in adults. This approval was based on data from Phase 3 clinical trials which showed that Edarbi successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP), with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Results from one study showed Edarbi at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3mmHg and 13.2mmHg from baseline, respectively. The blood pressure reductions of Edarbi (80 mg/day) were statistically superior to those of the active comparators valsartan 320mg/day (-10mmHg) and olmesartan medoxomil 40mg/day (-11.7mmHg). Similar results were observed in all three comparator studies.
Edarbi will be available in 40mg and 80mg dosage strengths.
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