Wednesday, December 7, 2011
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.
The FDA often follows an advisory panel’s recommendation but isn’t required to do so. The FDA is expected to approve or reject peganesatide by March 27.