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news.The US based Takeda Global Research & Development Center, a subsidiary of the Japan-based Takeda Pharmaceutical Company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD).
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Discovered by Takeda, the compound is indicated for the treatment of hypertension, or high blood pressure.
Azilsartan medoxomil is an angiotensin II receptor blocker (ARB) which lowers blood pressure by blocking angiotensin II action, a vasopressor hormone.
On the other hand, chlorthalidone is a long-acting oral thiazide-like diuretic used to treat hypertension.
Four phase 3 clinical trials involving more than 4,000 patients with hypertension support the NDA submission.
In a phase 3 clinical trial, azilsartan medoxomil (20 mg/day, 40 mg/day and 80 mg/day) was combined in with CLD (12.5 mg/day and 25 mg/day) in a fixed-dose, and was studied versus azilsartan medoxomil and CLD monotherapies.
In other studies, the fixed-dose combination of azilsartan medoxomil and CLD was compared to azilsartan medoxomil co-administered with hydrochlorothiazide (HCTZ), another diuretic, and with a fixed-dose combination of olmesartan medoxomil and HCTZ.
The 10-week, double-blind, randomized study compared the effect of CLD and HCTZ — both in combination with azilsartan medoxomil – on systolic and diastolic blood pressure by clinic blood pressure measurement and by ambulatory blood pressure monitoring in 609 patients with hypertension.
Takeda Global Research & Development Center vice president of Clinical Science Darryl Sleep said the company believes this compound, the first in the US to combine an ARB with chlorthalidone, has the potential to provide a new treatment option for patients with hypertension.