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FDA approves azilsartan medoxomil tablets for hypertension treatment
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The FDA today announced the approval of azilsartan medoxomil, an angiotensin II receptor blocker, for the treatment of hypertension in adults.
Azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceuticals) will be made available in 80 mg and 40 mg doses. The agency approved the drug based on data from more than 5,900 patients showing that azilsartan medoxomil was more effective at lowering 24-hour BP than valsartan (Diovan, Novartis) and olmesartan (Benicar, Daiichi Sankyo).
The 40 mg dose, according to a press release, will be available for patients taking high-dose diuretics.
“High BP is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs Products at the FDA’s Center for Drug Evaluation and Research, said in the press release. “High BP remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
The boxed warning that accompanied azilsartan medoxomil specified that the drug not be used in pregnant women during the second or third trimester.
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