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The sNDA filing was based upon data from the pivotal registrational trial, which provided estimates of the probability of patients attaining blood pressure goals with AZOR compared to amlodipine or olmesartan medoxomil alone.
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"Research suggests that more than two-thirds of patients often require multiple medications to help achieve blood pressure goals," said Matthew R. Weir, MD, University of Maryland School of Medicine, Department of Nephrology. "If approved, this filing would support JNC-7 guideline recommendations to start patients likely to need multiple antihypertensive agents to reach their blood pressure goal on combination drugs as initial therapy."
High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the body.(1) Hypertension is one of the most prevalent conditions in the United States affecting approximately one in three American adults (about 73 million people age 20 and older) and approximately one billion people worldwide.(2,3) It is often difficult to control, and of those with high blood pressure, approximately 65 percent do not have the condition under control.(4) The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025.(5)
"Given the prevalence of patients with high blood pressure, the approval of AZOR as initial therapy would give physicians a valuable treatment option to help more patients reach their blood pressure goal," said William R. Sigmund II, MD, Daiichi Sankyo Vice President of Medical Affairs. "Research and innovation in cardiovascular care is a therapeutic focus for Daiichi Sankyo, and expansion of AZOR's label is in line with our vision to contribute to the health of people in the United States."
About AZOR
AZOR is a convenient, once daily, single tablet combination of amlodipine, the most prescribed CCB on the market(6), which inhibits the entrance of calcium into the blood vessel walls, with olmesartan medoxomil, the active ingredient in Benicar(R), which blocks angiotensin II receptors. Angiotensin II is a hormone that causes blood vessels to tighten and narrow. Together the two medicines relax the blood vessels so that blood can flow more easily. Benicar (olmesartan medoxomil), Daiichi Sankyo's flagship ARB product, is the fastest growing medication in the fastest growing class of blood pressure-lowering drugs.(7)
The U.S. Food and Drug Administration (FDA) granted marketing approval for AZOR in September 2007. AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Presently, AZOR is not indicated for the initial therapy of hypertension. AZOR may be substituted for its individually titrated components. AZOR may also be used to provide additional blood pressure lowering for patients not adequately controlled with any calcium channel blocker or any angiotensin receptor blocker alone. In the pivotal registrational trial, AZOR demonstrated that eight weeks of double-blind treatment with combination therapy resu
