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The FDA on Friday recommended modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Johnson & Johnson’s Procrit (Epoetin alfa) and Amgen’s Aranesp (darbepoetin alfa) and Epogen (Epoetin alfa), in patients with chronic kidney disease (CKD). The agency noted that the modified recommendations are based on data from clinical trials, including the TREAT study, which showed that using ESAs to target a hemoglobin level of greater than 11 g/dL increased the risk of serious adverse cardiovascular events and provided no additional benefit to patients.

For patients on dialysis, the revised label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the hemoglobin level approaches or exceeds 11 g/dL. For patients not on dialysis, the label suggests that physicians consider initiating ESA therapy when the hemoglobin level is below 10 g/dL, and that physicians reduce or interrupt the dose when the hemoglobin exceeds 10 g/dL. This guidance replaces the previous label language recommending a hemoglobin target range of between 10 g/dL and 12 g/dL. The FDA is also approving modifications to the existing Risk Evaluation and Mitigation Strategy for ESAs.

Robert Kane of the FDA’s division of hematology noted that "the goal is to individualise therapy and use the lowest dose possible to reduce the need for red blood cell transfusions," adding that there is no way to make an all-purpose dosing recommendation that covers all patients.

Commenting on the label updates, Amgen’s executive vice president of R&D Roger Perlmutter noted that "Amgen supports the modified ESA prescribing information as it informs physicians of important safety information." Thomas Schaible, vice president of medical affairs at Janssen added that "Procrit is an important treatment option for patients with CKD-associated anaemia who are not on dialysis and are likely to require transfusion," adding that "the revised label provides additional clarification to prescribers on how to use Procrit in this patient segment."

ISI Group analyst Mark Schoenebaum noted that the new recommendations will reduce the average dose by a third, and suggested that projections for Epogen’s 2011-2013 sales "will likely need to come down." However, Deutsche Bank analyst Robyn Karnauskas said most investors have already priced the labeling changes into sales expectations, with most anticipating sales of ESAs to decline by 8 percent in 2012.

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