January 6th, 2010

Wednesday News Roundup: FDA to Reevaluate ESAs, Aspirin Underuse in REACH, & more…

In an NEJM perspective, four FDA officials review the sorry history of erythropoiesis-stimulating agents (ESAs) and call for randomized trials to establish “the optimal hemoglobin target, dosing algorithm, and monitoring approach” for these drugs. They also announce that the FDA intends to convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease.”

One-quarter of US patients with vascular disease are not receiving aspirin for secondary prevention, according to a report by Chris Cannon et al from the REACH Registry published online in the American Journal of Cardiology.

The FDA gave guidance to ARYx Therapeutics (press release) on the development path for its anticoagulant tecarfarin, which stumbled last summer in a test against warfarin.

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