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FDA panel supports anaemia drugs

Advisors to the US Food and Drug Administration have recommended against the restriction of anaemia drug darbepoetin alfa despite concerns

An advisory committee to the US Food and Drug Administration (FDA) voted on Tuesday to recommend that the federal agency not restrict the use of the anaemia drug darbepoetin alfa, which is sold as Aranesp, Epogen and Procrit, in patients with chronic kidney disease, despite data showing a link to an increased risk of stroke.

Aranesp and Epogen are manufactured and marketed by Amgen, while Procrit is made by Amgen but sold by Johnson & Johnson's Centocor Ortho unit. The drugs had combined sales of $6.3bn in 2009.

At the meeting, members of the Cardiovascular and Renal Drugs Advisory Committee voted 15-1, with one abstention, that the drugs should continue to be used for patients with chronic kidney disease who do not receive dialysis. In addition, the panel members voted against the idea of a fixed, limited dose of the drug in kidney patients who are on dialysis or in those who have a history of stroke, arguing that doctors should have the flexibility to make decisions based on the needs of individual patients.

The safety concerns about stroke stem from a recent Amgen study that was intended to show that high doses of Aranesp had cardiovascular benefits, but instead revealed that patients with kidney disease who were taking the drug were twice as likely as those on placebo to have a stroke. The phase III study, called TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy) was the largest-ever study of the drug in chronic renal failure patients.

Amgen updated the warnings on all three drugs' labelling last year to describe the specific stroke risk found in TREAT, thereby strengthening a cardiovascular boxed warning that had been in place since 2007.

At the advisory committee meeting, Amgen proposed further changes to the labelling that would limit treatment to patients most likely to benefit, specifically those with significant anemia and those at high risk for transfusion and for whom transfusion avoidance is clinically important. In addition, the company proposed a more conservative dosing algorithm in those patients.

20th October 2010

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