FDA experts back Bristol blood pressure drugAvalide could get approved for wider patient population, if agency regulators follow the expert advice.NEW YORK (CNNMoney.com) -- FDA advisers voted Wednesday in favor of approving Bristol-Myers' blockbuster blood pressure drug for a wider use, the company and the FDA said. The Food and Drug Administration's panel of seven experts voted unanimously to expand the use of Bristol's (up $0.07 to $28.36, Charts, Fortune 500) Avalide to patients who have not been previously treated for high blood pressure.
The drug, part of an Avalide-Avapro franchise that totaled $1.1 billion in 2006 sales, is currently approved only for hypertension patients who have failed other types of treatment. The nonbinding vote is taken into consideration by FDA regulators when they decide at a later date whether to approve the drug. However, approval won't have much of an impact on company sales, according to analysts, who say the drug is already prescribed "off-label" for untreated patients. FDA spokeswoman Kimberly Rawlings said the advisers were still determining whether the Avalide expansion should include only severe hypertension, or include both severe and moderate hypertension. Dr. Tim Giles, a cardiologist and professor of medicine at Tulane University who spoke at the panel hearing in Maryland, told CNNMoney.com that expansion of the use of Avalide would be "crucial" in reducing the risk of heart attacks, renal disease and especially stroke. Bristol is the sixth-largest U.S. drug company in terms of sales, behind Johnson & Johnson (down $0.13 to $64.42, Charts, Fortune 500), Pfizer (down $0.14 to $26.76, Charts, Fortune 500), Merck (down $0.20 to $49.81, Charts, Fortune 500), Abbott Laboratories and Wyeth.. |
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