FDA Approval: Edarbi

FDA approves Edarbi to treat high blood pressure (source: FDA Press Announcement)

On Friday, February 25, 2011, The U.S. Food and Drug Administration approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

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.”

Edarbi 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.

Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 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 taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo).

Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.

Edarbi is made by Takeda Pharmaceutical North America of Deerfield, Ill.

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