LIMITED US APPROVAL RECOMMENDED FOR HIVID

Following closely on from the first full approval of the product in Austria (Marketletter April 20), an advisory panel to the US Food and Drug Administration has recommended approval of Hoffmann-La Roche's antiviral drug Hivid (zalcitabine) for the treatment of AIDS, provided it is used in combination with Wellcome's Retrovir (zidovudine).

The committee's recommendation is that zalcitabine enters into the FDA's "fast-track" accelerated approval process, based on its appraisal of Roche's New Drug Application, which was submitted in October of last year and contained clinical data detailing the safety and efficacy of zalcitabine both on its own and in combination with Retrovir. The recommendation comes as the first formal test of FDA commissioner David Kessler's recently-outlined accelerated-approval policy.

However, although the Austrian government approved the use of zalcitabine as a monotherapy in patients who cannot tolerate Retrovir, the FDA panel has voted by 8-3 not to recommend approval of the drug in these patients. The FDA is not obliged to accept the rulings of its advisory committees, but in general the agency attaches considerable weight to their pronouncements.