FDA Directs Amgen to Revise ESA Labeling

August 4, 2008
Chitra Sethi

Chitra Sethi, Managing Editor, BioPharm International

The FDA has ordered Amgen and Johnson & Johnson to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit.

The US Food and Drug Administration has ordered Amgen (Thousand Oaks, CA) and Johnson & Johnson (New Brunswick, NJ) to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit.

The changes clarify the FDA-approved conditions for using ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated

Amgen submitted labeling supplements for Epogen/Procrit and Aranesp on May 22, 2008, following the March 13, 2008 Oncologic Advisory Committee?s recommendations to make additional safety-related changes to the labeling for these products.

The FDA has now ordered the new label to include that the drugs shouldn't be used in cancer patients receiving myelosuppressive therapy when a cure of the condition is anticipated.

The agency also ordered inclusion of a statement that the drugs aren't to be administered when hemoglobin levels are greater to or equal to 10 g/dl and that usage should stop if the hemoglobin exceeds a level needed to avoid transfusion.

Amgen issued the following statement in response to the receipt of the complete response on the revised ESA labeling from the FDA: "This label is consistent with our expectations. We will soon be communicating the revised product labeling for ESAs to both physicians and patients."