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www.fdanews.com/articles/101576-bms-and-sanofi-aventis-hypertension-drug-approved-for-additional-use

BMS and Sanofi-Aventis Hypertension Drug Approved for Additional Use

November 28, 2007

The FDA has approved sanofi-aventis and Bristol-Myers Squibb’s (BMS) supplemental new drug application for initial use of their antihypertensive drug Avalide in patients with hypertension who are likely to need multiple drugs to lower their blood pressure.

The approval is based on data from two clinical trials involving more than 1,200 patients with moderate or severe high blood pressure. In the first study, which was double-blind, active-controlled and lasted for seven weeks, patients with severe hypertension were randomly treated with either Avalide (irbesartan-hydrochlorothiazide) or Avapro (irbesartan), a hypertension drug that makes up part of Avalide. After five weeks, the patients on Avalide had greater mean blood pressure reductions than those on Avapro alone.

Avalide is approved for patients whose blood pressure is not adequately controlled on monotherapy. In the third quarter, BMS’ sales of Avapro and Avalide totaled $309 million, a 12 percent increase, including U.S. sales of $176 million, an 11 percent increase.