FDA panel rejects proposal for hemoglobin levels for Amgen, J&J


WASHINGTON A panel for the Food and Drug Administration has rejected an FDA proposal for a specific target hemoglobin level for anti-anemia drugs by Amgen and Johnson & Johnson that are used for patients with kidney failure.

The vote was 14 to 5 against a question that asked whether the FDA should target a measure of red blood cells at 11 grams per deciliter in patients who are also on dialysis.  Several panel members agree with the drug companies that the target range should be between 10 and 12 grams.

Paul Eisenberg, Amgen's vice president of global regulatory affairs and safety, said "we believe the data do demonstrate there is risk when you target a hemoglobin above 13 (grams), but achieving a target of greater than 11 grams per deciliter is associated with better outcomes" explaining why the companies are seeking a range of 10 grams to 12 grams.

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