FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Lifts REMS Requirements for Amgen’s Aranesp, Epogen and Procrit

April 19, 2017

Based in part on the results of program assessments submitted by Amgen, the FDA determined that the REMS for Aranesp, Epogen and Procrit is no longer necessary.

The three agents are used to treat anemia associated with chemotherapy, by stimulating bone marrow to produce red blood cells.

The REMS Assessment showed prescribers know the risks of decreased survival and/or the increased risk of tumor progression or recurrence and the need to counsel patients about the risks. In addition, drug utilization data showed appropriate prescribing of the intended use as a treatment alternative to red blood cell transfusion. While the REMS is no longer necessary to ensure benefits, the serious risks remain, the FDA said.

The FDA evaluated multiple actions, including the REMS, using sponsor-submitted data from outpatient oncology practices between 2006 and 2014. From 2004 to 2009, the FDA took multiple regulatory actions, including requiring labeling changes. Full implementation of the REMS in 2011 had minimal impact on prescribing and utilization trends, leading the FDA to conclude it was no longer necessary to require the certification of prescribers and hospitals.

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