Takeda files US NDA for combo hypertension drug; gets new indications for Nesina in Japan

The US affiliate of Japan’s largest drugmaker, Takeda Pharmaceutical ((TSE: 4502), has submitted a New Drug Application to the Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for the treatment of hypertension.

Discovered by Takeda, azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Chlorthalidone is a long-acting oral thiazide-like diuretic used in the treatment of hypertension. The NDA submission was supported by four Phase III clinical trials involving more than 4,000 patients with hypertension.

“Millions of patients with hypertension do not have their condition under control,” said Darryl Sleep, vice president, clinical science, Takeda Global Research & Development Center in the USA. “We believe this compound, the first in the USA to combine an ARB with chlorthalidone, could potentially provide an important new treatment option for patients with hypertension and the health care providers who manage them,” he added.