FDA Approves High Blood Pressure Drug


March 1, 2011

March 1, 2011 – The U.S. Food and Drug Administration (FDA) approved azilsartan medoxomil to treat high blood pressure (hypertension) in adults. Azilsartan medoxomil, also known as Edarbi, is made by Takeda Pharmaceutical North America.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).

“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the division of cardiovascular and renal drug products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”

Tablets will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.

Nearly one in three adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure and death.

Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

Adverse reactions reported by patients in clinical trials were similar to those reported by those taking an inactive drug (placebo).

For more information: www.tpna.com