Takeda seeks U.S. approval of hypertension drug

Japan’s Takeda Pharmaceutical Co said on Wednesday it submitted a new drug application in the United States for a hypertension drug.

A U.S. subsidiary of Takeda, Japan’s largest drugmaker, submitted the application to the U.S. Food and Drug Administration after completing four phase 3 clinical trials with more than 4,000 hypertension patients.

Hypertension, or High Blood Pressure, affects nearly one in three adults in the United States.

If the application holds up to a preliminary review, the FDA typically decides whether to approve a drug for sale within about 10 months.

The new drug combines azilsartan medoxomil, a medication discovered by Takeda that lowers blood pressure by blocking a certain hormone, with chlorthalidone, a long-acting oral diuretic.

“Millions of patients with hypertension do not have their condition under control,” said Darryl Sleep, vice president of clinical science for Takeda Global Research & Development Center, Inc. U.S., a subsidiary of the Japanese pharmaceutical company.

Sleep added that the new compound “could potentially provide an important new treatment option for patients with hypertension and the health care providers who manage them.”

The American Heart Association found that hypertension accounted for more than $73 billion in U.S. healthcare expenses in 2009.

(Reporting by Jasmin Melvin; Editing by Gary Hill)

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(Reuters)