Avandia, Meridia… now it’s Aranesp’s turn before the FDA

The FDA Death Panel Cardiovascular and Renal Drugs Advisory Committee will consider the fate of darbepoetin alfa (Aranesp) on October 18. Having failed to impose the death penalty on rosiglitazone (Avandia) and Meridia (sibutramine) in recent months, it appears likely the committee will not recommend withdrawal of the drug, though in the absence of any evidence of substantial benefit additional restrictions appear likely.

After many years of billion-dollar sales despite the lack of supporting data, ESAs (erythropoiesis-stimulating agents) came under increased scrutiny by the FDA in 2007 . Then last year the publication of TREAT raised new concerns. In a “Perspective” in the New England Journal of Medicine in January of this year FDA officials said they would convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease.”

Here is the agenda for the meeting as contained in the FDA announcement:

The committee will consider the results and analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP (darbepoetin alfa), manufactured by Amgen, Inc. This meeting is a follow-up to the September 2007 advisory committee meeting at which the committee discussed updated information on the risks and benefits of erythropoeisis-stimulating agents (drugs that stimulate production of red blood cells), marketed under the brand names ARANESP, EPOGEN, and PROCRIT, manufactured by Amgen, Inc., when used in the treatment of anemia (low red blood cell counts) due to chronic kidney failure.

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