(ATN) 566C80 (Atovaquone): FDA Advisory Committee Recommends Approval for Pneumocystis Treatment

(ATN) 566C80 (Atovaquone): FDA Advisory Committee Recommends Approval for Pneumocystis Treatment

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

On September 24 the FDA Antiviral Drug Products Advisory Committee also recommended approval of 566C80 (also called atovaquone), a drug developed by Burroughs Wellcome Company, for treating pneumocystis. The committee recommended that the drug be used as second-line treatment, if trimethoprim/sulfamethoxazole (TMP/SMX, commonly known as Septra, or Bactrim) could not be tolerated or failed to work. Trials had shown that TMP/SMX was more likely than 566C80 to be effective against pneumocystis, but also more likely to be discontinued because of side effects. The importance of 566C80 is to offer another pneumocystis treatment option for those times when it is needed.

566C80 might also be useful in treating toxoplasmosis.

FDA approval of 566C80 is expected in the next several weeks or months. Meanwhile, a Burroughs Wellcome "treatment IND" program which started in November 1991 will continue to be available for those who need the drug now; there is also a similar "compassionate release" system for use outside North America. More than 800 patients have been treated in these programs. To enroll a patient in the treatment IND, physicians can call 800/755-2020, 7 days a week 24 hours a day.

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