FDA Panel Backs Drug for AIDS-Related Pneumonia
Final marketing approval for aerosol Pentamidine, a drug to prevent AIDS-related pneumonia, was unanimously recommended Monday by a Food and Drug Administration advisory committee.
FDA officials said the drug, made by Lyphomed Inc. of Melrose Park, Ill., could gain final agency approval “in a matter of weeks.”
The drug is already widely available to AIDS patients in this country under a special FDA effort to cut through red tape when desperately ill or dying patients are involved.
After reviewing research results and hearing two hours of testimony from the public, the committee concluded that aerosol Pentamidine is safe and its benefits outweigh its risks in the prevention of AIDS-related pneumonia.
Researchers who had evaluated the drug in a trial involving 408 patients in the San Francisco area told the panel it reduced the risk fourfold when given once a month in a 300-milligram dose, compared to a 30-milligram dose.
FDA staff reviewers said more study is needed to gauge the drug’s long-term side effects and benefits, but recommended approval nonetheless.
The same panel today will review the safety and effectiveness of another drug for an AIDS-related infection. It will examine a drug called Ganciclovir, made by Syntex Corp. of Palo Alto.
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