(ATN) Rifabutin: FDA Advisory Committee Recommends for MAC Prophylaxis

(ATN) Rifabutin: FDA Advisory Committee Recommends for MAC Prophylaxis

AIDS Treatment News #160, October 2, 1992
John S. James

On September 24 the FDA's Antiviral Drug Products Advisory Committee recommended the approval of rifabutin (brand name Mycobutin) for prevention of MAC. Two studies conducted by the drug's sponsor, Adria Laboratories, found that volunteers with T-helper counts less than or equal to 200 developed MAC bacteremia (shown by positive blood cultures) about half as often in the group given rifabutin, compared to the group given a placebo.

The FDA is not required to follow the recommendations of its advisory committees, but it almost always does so. Official approval of rifabutin is expected in the coming weeks or months.

For more information about rifabutin, see the interview with Kenneth Mayer, M. D., in this issue.

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