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news.Takeda Global Research & Development Center has submitted a new drug application (NDA) to the FDA for Azilsartan medoxomil, an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension.
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Discovered by Takeda, Azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.
Takeda Pharmaceutical said that the NDA submission was supported by seven Phase 3 clinical trials involving more than 5,900 patients.
The safety and efficacy of Azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or in combination with other antihypertensive medications, including chlorthalidone and amlodipine, and was also studied in comparison to olmesartan medoxomil, valsartan and ramipril.
Nancy Joseph-Ridge, general manager of pharmaceutical development division of Takeda, said: “The NDA submission for Azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda.
“We are proud to build upon our global expertise in the cardiovascular therapeutic area with this filing, and believe this compound, once approved, will provide an important treatment option for hypertensive patients and the health care providers who manage them.”