FDA approves azilsartan medoxomil to treat hypertension

February 28, 2011

FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.

FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults. Azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

Data from clinical studies showed azilsartan medoxomil to be more effective in lowering 24-hour blood pressure compared with 2 other FDA-approved hypertension drugs, valsartan (Diovan) and olmesartan (Benicar).

“Azilsartan medoxomil represents another addition to the armamentarium for the treatment of hypertension,” said Robert T. Taketomo, PharmD, MBA, president/CEO and chairman of the board for Ventegra LLC, a Glendale, Calif.-based managed care contracting-services organization that represents payers, providers, PBMs, and government programs. “Although the pivotal trials demonstrated statistical superiority over placebo, olmesartan [Benicar], and valsartan [Diovan], it will be interesting to see how this will translate into clinical superiority and effectiveness. Since many agents used to treat hypertension are generically available, the pricing strategy for this agent will also be critical.”

Azilsartan medoxomil 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.

Adverse reactions reported by patients taking azilsartan medoxomil in clinical trials were similar to those reported by those taking placebo. Azilsartan medoxomil has a boxed warning stating that use of the drug should be avoided by 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.

Nearly 1 in 3 adults in the United States have high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.