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FDA panel backs Affymax anemia drug for dialysis patients
San Francisco Business Times

A federal advisory panel Wednesday approved Affymax Inc. ’s once-a-month anemia drug for kidney dialysis patients. The 17-member Food and Drug Administration panel of outside experts recommended that the agency approve peginesatide from Palo Alto-based Affymax (NASDAQ: AFFY) and partner Takeda Pharmaceuticals . Two Phase III studies showed that the drug is safe and effective for dialysis patients, but two other late-stage studies found that peginesatide could cause heart problems in kidney patients who weren’t yet on dialysis.