FDA Approves Edarbi to Treat Hypertension

February 28, 2011

The U.S. Food and Drug Administration has approved Edarbi tablets (azilsartan medoxomil) to treat hypertension in adults.

The U.S. Food and Drug Administration has approved Edarbi tablets (azilsartan medoxomil) to treat 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,” Norman Stockbridge, MD, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 mg 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. 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.