| News From Transplant Week of January 27, 2002 / Vol. 3 No. 4 |
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FDA Advisory Panel Votes Against New Regimen for Rapamune |
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A U.S. Food and Drug
Administration advisory panel has voted 5-to-4 against American
Home Products Corp.'s proposal to change the approved regimen
for its transplant immunosuppressive drug Rapamune. The FDA in 1999 approved marketing Rapamune for helping prevent rejection of transplanted kidneys. The approved treatment calls for Rapamune to be used with together with the drug cyclosporine and with corticosteroids. American Home Products is seeking to change the label to recommend withdrawal of cyclosporine after two to four months, and submitted studies showing that eliminating cyclosporine resulted in better kidney function after one year. But a narrow majority of members of the advisory panel concluded that the data did not satisfactorily prove that the new regimen was safe and effective. Dr. Joseph Camardo, a Wyeth-Ayerst senior vice president, said the company would continue discussions with FDA officials, and said it was unclear whether the FDA would follow the recommendation of its advisory committee. Obtaining an FDA-approved label change would allow the company to market the new regimen to doctors. Other sources: FDA, Wyeth-Ayerst |
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