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news.Takeda Pharmaceutical Company and its wholly-owned subsidiary Takeda Pharmaceuticals North America have made hypertension drug Edarbi (azilsartan medoxomil) available in US pharmacies.
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Developed by Takeda, Edarbi is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure in adults.
Edarbi may be used either alone or in combination with other antihypertensive agents.
Results from the phase 3 clinical trials showed Edarbi met the primary endpoint, change in 24-hour mean SBP as measured by ABPM, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators.
Specifically, results from one study showed Edarbi at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively.
The blood pressure reductions of Edarbi (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg).
The FDA has approved an updated product labeling for Edarbi, which highlights the connection between lowering blood pressure and decreased risks of cardiovascular outcomes, including strokes and heart attacks.