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Off-Label Safety Signal For Affymax's Peginesatide Doesn't Dissuade ODAC, With Assurance Of Restricted Distribution

Executive Summary

There was a cardiovascular safety signal in two clinical trials of non-dialysis patients taking Affymax's peginesatide to treat anemia due to chronic kidney disease, but the Oncologic Drugs Advisory Committee concluded the drug's benefits are greater than its risks for patients on dialysis.

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