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The federal government Friday approved the experimental AIDS drug AZT for marketing in the United States, making it the first drug licensed in this country to treat the deadly disease.
Dr. Robert E. Windom, assistant secretary for health at the Health and Human Services Department, emphasized that AZT, to be sold under the trade name Retrovir, is not a cure for AIDS. But he said the action "means that significant medical relief will be available to thousands of those afflicted with this dreaded disease."
Windom said that licensing of the drug, which was recently approved for sale in France and Britain, "marks an important step but by no means a final victory in our ongoing war against AIDS."
AZT, or azidothymidine, is expected to be expensive, costing each patient as much as $10,000 a year.
Final approval of AZT, first administered to AIDS patients in human studies begun in July, 1985, came in record time, the result of a decision by the Food and Drug Administration to consider AIDS drugs as a top regulatory priority. Typically, the process takes an average of 8 1/2 years from the earliest studies to licensing.
"The agency will continue to follow up on post-marketing studies so that we can understand as much as possible about this drug," FDA Commissioner Frank Young said in an interview. "Nevertheless, we feel it is clearly appropriate to approve the drug at this time. New products will be passed through the regulatory process with as much compassion and dedication as humanly possible."
In another departure from usual procedures, distribution of AZT will be tightly controlled by its manufacturer, the Burroughs Wellcome Co., to ensure that only patients with AIDS and AIDS-related complex (ARC) who meet certain criteria can receive it, although the criteria appear flexible. Traditionally, once a drug is licensed by the FDA, there are no restrictions on how physicians...