FDA wants more data on new Aranesp doses

Shares of Amgen [1] slipped slightly on Friday after the biotech giant announced that the FDA wants a new clinical trial of its monthly dose of the anemia drug Aranesp in patients with chronic kidney disease not on dialysis. The agency also asked for more data on a once-every-two-weeks dose of Aranesp. Amgen, though, countered that it would ask the FDA to consider additional data on the new doses that was not available when it filed for approval. Aranesp was originally approved for anemia five years ago. Amgen is also facing new competition from Roche, which has submitted its anemia drug for kidney disease--Mircera--for FDA approval. Amgen has sued Roche for allegedly violating its patent on Epogen, an earlier anemia drug.

- here's the release [2] on Aranesp

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Aranesp may work for heart failure. Report [3]