FDA OKs combination azilsartan medoxomil, chlorthalidone

Takeda today announced FDA approval of combination azilsartan medoxomil and chlorthalidone to treat hypertension in adults, according to a press release.

Azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) is the only fixed-dose therapy in the United States to combine an angiotensin II receptor blocker with a diuretic. The recommended starting dose of the once-daily tablet is 40/12.5 mg; the maximum dose is 40/25 mg.

“The approval of [azilsartan medoxomil and chlorthalidone] provides an effective treatment option to lower BP for appropriate patients with hypertension who may require a combination of drugs to help achieve BP goals,” Domenic Sica, MD, professor of internal medicine and nephrology, Virginia Commonwealth University Medical Center, stated in a press release issued by Takeda.

The decision to approve azilsartan medoxomil plus chlorthalidone was based on five phase 3 clinical studies involving more than 5,000 hypertensive patients. The trials, ranging from 8 to 52 weeks in duration, showed that combination therapy was associated with greater improvements in blood pressure compared with either therapy alone or with the fixed-dose combination of high-dose olmesartan medoxomil plus hydrochlorothiazide.

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