Affymax preps for dialysis drug debut

After two decades, a name change for its lead product and damaging late-stage trial data a year ago, Affymax Inc. ’s first drug is ready for show time.
The Palo Alto company’s drug, called Peginesatide, could break Amgen Inc.’s virtual monopoly on treating anemia in kidney dialysis patients. In May, Affymax submitted its application for Food and Drug Administration approval of the drug.
In early or mid-August, the agency will say whether it accepts the 800,000-page application and set a target approval date, likely to be in early 2012.