AZOR Receives FDA Approval For Treatment Of High Blood Pressure
FDA has approved Daiichi Sankyo's AZOR (amlodipine and olmesartan medoxomil) for the treatment of hypertension, also known as high blood pressure. AZOR is a convenient, once daily, single tablet combination of amlodipine, the number one prescribed calcium channel blocker (CCB) on the market, and olmesartan medoxomil, the active ingredient in Benicar, which is the fastest growing angiotensin receptor blocker (ARB). The combination of these two medications will give doctors a powerful new treatment option for patients with hypertension who need to reduce their blood pressure levels or who are uncontrolled on other medications.
In clinical trials, AZOR produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension. According to the pivotal registrational trial, AZOR 10/40 mg reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison with mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, AZOR 10/40 mg resulted in a 53 percent greater reduction in the mean change of systolic blood pressure.
"AZOR is a valuable treatment addition, since so many people in the United States with hypertension do not have their blood pressure adequately controlled," said Michael A. Weber, MD, Professor of Medicine, State University of New York, Downstate College of Medicine. "AZOR with its established efficacy and favorable side effect profile provides two complementary mechanisms of action to lower blood pressure. It will give physicians a new treatment option for patients whose blood pressure remains too high on currently prescribed medications."
AZOR combines the complementary actions of the powerful CCB amlodipine which inhibits the entrance of calcium into the blood vessel walls, with olmesartan medoxomil, 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.
"The approval of AZOR represents an important milestone for our growing U.S. organization and underscores our continued commitment to helping more patients reach their recommended blood pressure treatment goals," said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc.
High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the body. Hypertension is one of the most prevalent conditions in the United States affecting approximately one in three American adults and approximately one billion people worldwide. It is often difficult to control, and of those diagnosed with high blood pressure, approximately 65 percent do not have the condition under control. The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025.
AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. AZOR is not indicated for the initial therapy of hypertension.