Red blood cells
The US Food and Drug Administration (FDA) has determined that the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs) is no longer necessary.
The REMS was limited to the use of epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) to treat patients with anemia due to myelosuppressive chemotherapy.
The FDA said the REMS is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh the risks these drugs pose, which include shortened overall survival and an increased risk of tumor progression or recurrence in patients with cancer.
The FDA has released the REMS requirements for these ESAs and said the risks the drugs pose can be communicated by the current product prescribing information.
The FDA decided the REMS is no longer needed based on its own analyses and an evaluation of the REMS assessment submitted by Amgen, Inc., the company that markets Epogen/Procrit and Aranesp.
Details on the analyses and evaluation are available from the following page on the FDA website: Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp).
