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Affymax's Peginesatide May Be Tough Sell To ODAC As ESAs Cast Long Showdow

This article was originally published in The Pink Sheet Daily

Executive Summary

Safety concerns over erythropoiesis-stimulating agents seem to extend to Affymax's peginesatide, and since it lacks an efficacy edges over these drugs in treating anemia due to chronic kidney disease, an approval basis is unclear.

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With FDA’s March 27 approval of peginesatide to prevent anemia in CKD patients on dialysis, Affymax will focus initially on marketing to smaller, price-conscious dialysis providers. But the biotech also expects to do business with Fresenius and, to a lesser degree, Davita.

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