P.M. BRIEFING : Wider Use OKd for AIDS Virus Drug
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WASHINGTON — The government today announced a plan for expanded distribution of a drug that appears to be effective in stopping replication of the AIDS virus.
The plan for wider distribution of dideoxyinosine, or ddI, marks the first time the Food and Drug Administration has agreed to make such an experimental drug so widely available so early in testing, the FDA said.
Under the plan, ddI will be available to about 2,600 people with AIDS or AIDS-related complex in controlled clinical trials to test the effectiveness of the drug against zidovudine, known as AZT.
The plan also will make ddI available to people with AIDS or advanced AIDS-related complex who cannot take AZT, the only FDA-approved drug that directly combats the AIDS virus, and those for whom the disease is progressing despite AZT and who have no other treatment options.
Bristol-Meyers, which holds the license to manufacture ddI, has said it will distribute the drug at no cost.
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