FDA Says Peginesatide Works As Good As Epoetin Alfa And Darbepoetin Alfa.

Bloomberg News  (12/6, Peterson, Edney) reports Affymax (peginesatide) "experimental anemia medicine works as well as drugs sold by Amgen Inc...and Johnson & Johnson...for patients with chronic kidney disease." The medication, "peginesatide, is 'non-inferior' to Amgen's Epogen [epoetin alfa] and Aranesp [darbepoetin alfa] and J&J's Procrit [epoetin alfa], Food and Drug Administration staff evaluating whether the product should be approved for sale said in a report today." The medication "had 'similar safety results' for patients on dialysis to Epogen and Procrit, according to the FDA staff report." The company is trying to receive approval "only for adult patients on dialysis," according to a statement posted today on the agency's website. The agency should rule on the application by March 27. Also covering the story is Reuters  (12/6, Selyukh).