WASHINGTON -- An FDA advisory committee will meet onApril 20 and 21 to review three AIDS issues: HoffmannLaRoche's application for use of ddC to treat HIV infection; theuse of CD4 cell count as a surrogate marker in studies of drugsto treat HIV; and new clinical data related to Bristol-MyersSquibb's ddI treatment for the virus.
The Antiviral Drugs Advisory Committee will be discussing ddIand CD4 markers for the second time.
Last July, the panel recommended approval of Squibb's ddI(dideoxyinosine) for patients who cannot tolerate or fail torespond to Burroughs Wellcome's anti-AIDS drug AZT.
The FDA approved the drug for this indication last October. Theapproval was based on interim end points, and the committeeindicated that it expected randomized clinical trials to becompleted. The committee will review these trials at the Aprilhearing.
On the surrogate marker issue, the committee unanimouslyrecommended in November that the FDA use clinical end pointsrather than changes in CD4 count to gauge the efficacy of HIVvaccines. Committee members stressed that more study wasneeded because surrogate markers are a novel biologic conceptand a therapeutic HIV vaccine is a novel mechanism.
Roche's ddC (dideoxcytidine) new drug application was filed inNovember. The application included information on ddC'ssafety and efficacy in AIDS when used alone and incombination with AZT.
-- Steve Usdin BioWorld Washington Bureau
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