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Hypertension Drug Labeling Would Benefit From Responder Analysis

Advisory committee members say they’d feel better about approving combo products for hypertension if labeling included pivotal trial data enabling clinicians to assess how individual patients fared on therapy.

As the U.S. health care system moves toward personalized medicine, participants in a recent FDA advisory committee meeting called for responder analyses from pivotal studies to be included in the labeling of newly approved antihypertensive therapies as an ideal way to guide clinicians’ decision-making processes.

FDA’s Cardiovascular and Renal Drugs Advisory Committee convened on Sept. 9 to assess Allergan PLC’s NDA for a fixed-dose combination product for high blood pressure composed of two previously...

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