An FDA panel voted 15-1 Monday to maintain Amgen's Aranesp (darbepoetin alfa) indication as a treatment for patients with anaemia associated with chronic renal failure (CRF) who are not on dialysis. The FDA initiated the review following the release of data from the TREAT trial, which demonstrated that Aranesp did not meet the study's goal of reducing death and cardiovascular events compared to placebo in patients with CRF who were not on dialysis.
Based on the results of this trial, a label warning of these risks was added to Aranesp, as well as Amgen's similar erythropoiesis-stimulating agents, Epogen (epoetin alfa) and Procrit (epoetin alfa), which the drugmaker markets through Johnson & Johnson. Panelists also voted 9-5 that use of the drug shouldn’t be limited to a "rescue therapy" for people with very low iron levels and 9-2 that the drug should not be restricted in kidney patients who are getting dialysis. "I don’t think we have enough evidence to make any changes right now," said panel member Henry Black.
Sanford C. Bernstein & Co. analyst noted that use of the drug in patients not on dialysis accounted for about $600 million of the $2.65 billion in revenue that Aranesp generated for Amgen in 2009, while RBC Capital Markets analyst Michael Yee speculated that eliminating pre- dialysis use may cut $200 million to $400 million from Amgen’s annual sales.
Reference Articles
Amgen to review results from TREAT and propose updates to ESA labeling for chronic renal failure patients at an FDA Advisory Committee meeting today - (Amgen)
Amgen’s anemia drug Aranesp is safe before dialysis - (Bloomberg)
US panel cautiously backs Amgen anemia drugs - (Forexpros)
FDA panel backs anemia drugs for kidney disease - (MSN Money)
FDA panel backs use of Amgen's Aranesp for kidney disease patients (free preview) - (The Wall Street Journal)
**Published in "First Word"
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