Daiichi Sankyo Gets FDA Approval For AZOR(R) - First-Line Treatment for High Blood Pressure
Wed, 05/13/2009 - 4:40am
Daiichi Sankyo, Inc. has announced that the FDA hasapproved the combination treatment AZOR(R) (amlodipine and olmesartanmedoxomil) as initial or 'first-line' therapy in patients likely to needmultiple antihypertensive agents to achieve their blood pressure (BP) goals.The FDA approval of AZOR for first-line use reinforces current U.S. guidelinesto prescribe combination drugs as initial therapy for patients likely to needmore than one drug. According to the Seventh Joint National Committee onPrevention, Detection, Evaluation, and Treatment of High Blood Pressure, more than two-thirds of hypertensive individuals are not controlled on onedrug and require two or more medications selected from different drug classesto achieve their BP goal. "The approval of AZOR as a first-line therapy gives doctors an importanttreatment option that may help the many patients who require multiplemedications avoid several treatment steps to achieve their blood pressuregoals," said Dr. Keith C. Ferdinand, M.D., chief science officer, Associationof Black Cardiologists and clinical professor, Emory School of Medicine."Fixed-dose combinations like AZOR provide patients with a more convenientoption than separate monotherapies, which may help simplify the treatmentregimen and decrease overall pill burden." High blood pressure can cause permanent changes to blood vessels and theheart that may create serious problems elsewhere in the body. Hypertensionis one of the most prevalent conditions in the United States, affectingapproximately one in three American adults (about 73 million people age 20 andolder) and approximately one billion people worldwide. It is oftendifficult to control, and of those with high blood pressure, approximately 55percent do not have the condition under control. The number of people withhigh blood pressure is expected to reach about 1.6 billion worldwide by2025. "We are very happy to see that the FDA recognizes the need for thisimportant treatment option to help more patients reach their blood pressuregoals," said William R. Sigmund II, MD, Daiichi Sankyo Vice President ofMedical Affairs. "Given the prevalence of patients with high blood pressure,this approval shows the importance of the research and innovation incardiovascular care that is a therapeutic focus for Daiichi Sankyo."The AZOR(R) first line approval was based on data from the pivotalregistrational trial, which provided estimates of the probability of patientsattaining blood pressure goals with AZOR compared to amlodipine or olmesartanmedoxomil alone.