FDA clears Daiichi combo blood pressure medicine

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The FDA has approved Daiichi Sankyo's combination treatment Azor (amlodipine and olmesartan medoxomil) as initial or 'first-line' therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure (BP) goals.

The Parsippany, N.J.-based company said the approval of Azor for first-line use reinforces U.S. guidelines to prescribe combination drugs as initial therapy for patients likely to need more than one drug. According to the Seventh Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7), more than two-thirds of hypertensive individuals are not controlled on one drug and require two or more medications selected from different drug classes to achieve BP goal.

The Azor first line approval was based on 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, Daiichi said.

"Fixed-dose combinations like Azor provide patients with a more convenient option than separate monotherapies, which may help simplify the treatment regimen and decrease overall pill burden," said Keith C. Ferdinand, MD, chief science officer of the Association of Black Cardiologists and clinical professor at Emory School of Medicine in Atlanta.