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September 18, 1987

Approval of Zidovudine (AZT) for Acquired Immunodeficiency SyndromeA Challenge to the Medical and Pharmaceutical Communities

JAMA. 1987;258(11):1517. doi:10.1001/jama.1987.03400110099035

THE ANTI-INFECTIVE Advisory Committee to the Food and Drug Administration (FDA) recently recommended the approval of zidovudine (azidothymidine [AZT]) for use as a treatment of selected patients with acquired immunodeficiency syndrome (AIDS), but only for those with advanced illness characterized by Pneumocystis carinii pneumonia and depressed immunity and for symptomatic cases of AIDS-related complex (ARC). It did not, however, recommend approval of zidovudine for treatment of pre-AIDS or nonadvanced AIDS cases with other opportunistic infections. Within two months of that recommendation, the FDA released the drug for use for the above indications.

The committee, which I chaired, was made up of 11 medical experts in infectious diseases and other disciplines; it was asked to review data from one placebo-controlled clinical trial of patients with AIDS who had recovered from their first episode of P carinii pneumonia before enrollment and patients with ARC who had multiple clinical symptoms, such as oral