By Kevin E. Noonan --
The Food and Drug Administration posted a notice on its website today that further restricts prescription of two erythropoietin drugs (Amgen's Epogen®/Aransesp® and Johnson & Johnson's Procrit®) to cancer patients. The notice is part of the FDA's ongoing safety review of these drugs, and is a "follow-up" to a January 3, 2008 Official Communication.
In the notice, the FDA announced that it will require what it terms "safety-related" changes in how these drugs are labeled. The changes include replacing the Package Insert with a Medication Guide, and modifying particular sections of "the Boxed Warnings, Indications and Usage, and Dosage and Administration" portions of the package insert. Specifically, the hemoglobin level at which the drugs should not be administered to cancer patients has been changed. While the changes were developed by the FDA with Amgen's input and cooperation, the Agency and the company could not agree on the wording of a warning statement that these drugs are not intended for use in myelosuppressed patients where cure is the expected outcome, and statements relating to hemoglobin levels used to trigger initiation and termination of dosing.
The new labeling recommends that treatment should not be initiated until a patient's hemoglobin level falls to 10 grams per deciliter, and clarifies language suggesting that treatment be continued until hemoglobin levels of 12 grams per deciliter are produced. The labels also recommend that the drugs not be used as "adjuvant" therapy, in combination with chemotherapy after surgical resection. The FDA also decided to disregard a recommendation from its Oncologic Advisory Committee that these drugs not be used for certain types of cancer.
As reported today in The New York Times (see "Amgen Told to Reword Drug Label"), this is the first time the FDA has exercised its new authority under revisions to the Food, Drug and Cosmetic Act to mandate these types of labeling changes; previously the Agency was limited to negotiating with a drug manufacturer to accept a label change. The changes were motivated by studies that suggested that the use of these drugs to treat anemia associated with chemotherapeutic treatment could be deleterious. Despite this, Aransesp® has retained its traditionally strong sales; second quarter 2008 sales are reported to be $825 million. And according to the Times this performance exceeded expectations on Wall Street.
The company has five days to appeal and fifteen days to submit supplemental labeling in compliance with the FDA's changes to the label.
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