Amgen (AMGN) won another round recently as the European Union rewrote all the red-cell stimulating labels to recommend using these drugs, like Aranesp, when hemoglobin levels fall to 10 grams/deciliter, and not to try to increase hemoglobin above 12 grams/deciliter. I think everyone agrees that going above 12 grams/deciliter is a bad idea, and the current Aranesp label has that limit. So there is essentially no additional impact on Aranesp or Epogen sales from this decision.
On March 13, the FDA advisory committee will meet to review data from studies that raised hemoglobin levels above 12 grams/deciliter. The question is whether they should raise the current Aranesp label level, which they won't, but Wall Street is afraid the committee will take this opportunity to lower the limits. I don't think that will happen, and there should be a sharp reflex rally once we get past this last hurdle.
