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14 October 2010

FDA to review use of anaemia drugs in patients with chronic kidney disease

The FDA will convene its cardiovascular and renal drugs advisory panel to consider whether to impose further restrictions on the use of anaemia drugs sold by Amgen and Johnson & Johnson for patients with chronic kidney disease. The review comes in light of clinical trial data suggesting that erythropoiesis-stimulating agents (ESAs), such as Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa), can increase the risk of stroke and cardiovascular problems.
Data from the TREAT trial demonstrated that patients with chronic kidney disease who were not on dialysis who were receiving Aranesp had double the rate of strokes compared to patients receiving placebo. While the findings from this trial have already been reflected on Aranesp's label, US regulators are expected to ask panelists whether stronger warnings or additional restrictions are required. In addition, the agency is expected to ask panel members whether additional studies are "feasible and advisable to determine an effective dose regimen of Aranesp with an acceptable safety profile."
In a document posted to the FDA's website, Amgen said it supported a more "conservative" dosing recommendation for patients with chronic kidney disease who are not on dialysis, as well as updates to the products label. However, Amgen CEO, Roger Perlmutter, said use of the drugs should not be restricted entirely.
US regulators previously updated the labels of ESA's to warn that the products could shorten overall survival and increase tumour progression or recurrence in patients with breast, non-small-cell lung, head and neck, lymphoid and cervical cancers.
In 2009, Aranesp, Epogen and Procrit had combined US sales of $6.3 billion, down from a peak of $10 billion in 2006.


Reference Articles
FDA seeking panel advice on use of Amgen, J&J anti-anemia drugs - (NASDAQ)
FDA may limit anemia drug use for kidney disease - (Yahoo!Finance)

**Published in "First Word"

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