US FDA advisory panel backs continued use of Amgen's Aranesp and Epogen pre-dialysis, but calls for more studies

A US Food and Drug Administration advisory panel has voted near unanimously that biotech major Amgen’s (Nasdaq: AMGN) Aranesp (darbepoetin) and Epogen (epoetin alfa) and Johnson & Johnson’s (NYSE: JNJ) Procrit (epoetin alfa) should remain on the market for anemia patients who do not yet require dialysis, despite an increased risk of stroke as identified in the TREAT clinical study. Amgen’s stock rise 2.2% to $57.96 by 4pm after the recommendation.

At yesterday’s cardiovascular and renal drugs advisory panel meeting, convened to advise the FDA on erythropoiesis-stimulating agents (ESAs), experts voted 15 to one against ending use of these drugs before dialysis, nine to five against cutting dosing to patients with hemoglobin levels below 9 grams per deciliter of blood and nine to two (with two abstentions) that the drugs should not be restricted in kidney patients who are getting dialysis. However, the panel also recommended that more studies be undertaken to better explain which patients benefit from Aranesp and what dosing is ideal.

As a result of the TREAT study, a warning about the risk of stroke was added to Aranesp's label, as well as for Epogen and Procrit. The FDA asked the advisory panel whether additional steps are needed beyond the label change. Since the new labeling, US sales of the ESAs have declined, falling from around $10 billion in 2006 to $6.3 billion in 2009.