Edarbi approved for treatment of hypertension

EDARBI (azilsartan medoxomil) 40mg and 80mg tablets by Takeda Pharmaceuticals North America
EDARBI (azilsartan medoxomil) 40mg and 80mg tablets by Takeda Pharmaceuticals North America
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.

For more information call (877) 825-3327 or visit www.tpna.com.