B-MS Files For New Zerit Indication

Bristol-Myers Squibb has filed a supplemental New Drug Application with the US Food and Drug Administration for an expansion of the indications for its anti-HIV drug Zerit (stavudine) to reflect recent clinical findings (see also pages 24-25).

The request is based on positive, final results of a randomized, double-blind trial of Zerit versus continued treatment with Glaxo Wellcome's Retrovir (zidovudine) in 822 HIV-infected adults with CD4 lymphocyte counts between 50 and 500/mm3 and at least 24 weeks of prior zidovudine treatment. Zerit is currently indicated for adults with advanced HIV disease who are intolerant to other approved therapies, or who show clinical or immunological deterioration while on these therapies.