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Affymax, Inc. Message Board

  • jeremyrobertscheel jeremyrobertscheel Mar 16, 2013 8:07 PM Flag

    FDA stated, results of the pivotal trials

    The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension), and joint, back, leg, or arm pain (arthralgia),” FDA said in its press release announcing approval of the Affymax drug. However, the agency approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS) designed to enhance patient safety by requiring additional education for healthcare professionals as well as an assessment of drug use data.

    Despite these precautions, FDA stated, results of the pivotal trials “showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter."

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