PRINCETON, N.J. and PARIS Bristol-Myers Squibb and Sanofi-Aventis have received approval from the Food and Drug Administration for their supplemental new drug application for the antihypertensive drug Avalide, for patients with hypertension who most likely need multiple drugs to achieve their blood pressure goals.
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 or Avapro, 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 of 2007, BMS’ sales of Avapro and Avalide totaled $309 million, a 12 percent increase from the same period last year.