FDA experts back Bristol blood pressure drug

Avalide could get approved for wider patient population, if agency regulators follow the expert advice.

By Aaron Smith, CNNMoney.com staff writer

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.. Top of page

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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer. Morningstar: © 2018 Morningstar, Inc. All Rights Reserved. Factset: FactSet Research Systems Inc. 2018. All rights reserved. Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor's Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2018 and/or its affiliates.