Subject: Application to FDA Seeks Wider Use of AIDS Drug
Date: Published: 6/2/92 (31 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology Brief -- Bristol-Myers Squibb Co.:
    Application to FDA Seeks
    Wider Use of AIDS Drug

    Bristol-Myers Squibb Co., New York, submitted an
 application to the Food and Drug Administration to expand the
 use of its AIDS drug Videx (DDI) even though an advisory
 panel last April declined to recommend any label change.
    The company is seeking to make the drug available to
 patients who have had four or more months of therapy on
 Wellcome PLC's drug AZT.  The FDA licensed DDI last fall for
 use as a fallback treatment for patients who fail to improve
 on AZT, or who cannot tolerate AZT's side effects, mainly
 anemia.  In April, armed with a study suggesting that DDI is
 superior to AZT in reducing secondary infections in patients
 with AIDS-related complex, the company asked the advisory
 panel whether the label should be expanded.  The panel said
 no. 
    A Bristol-Myers spokeswoman said the company didn't submit
 a formal application during the April session.  "It was not a
 formal vote," she said, adding that the panel's
 recommendations aren't binding.
    The FDA couldn't be reached for comment.

[This article is made available here by Dow Jones Co. for the
 personal and non-commercial use of callers to this bbs, in the
 hope that it will be of some help to those who are suffering
 from the disease and others who are seeking to help them.]