ESAs in the News

Amgen Statement on Posting of Briefing Documents for the Review of TREAT Results at the FDA’s CRDAC Meeting

The U.S. Food and Drug Administration (FDA) today posted FDA and Amgen briefing documents on its website for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting on October 18, 2010, which will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy). The materials are now available at the FDA website.

At the CRDAC meeting, Amgen will provide a robust review of the results from TREAT and discuss how the study informs the nephrology community about the appropriate use of erythropoiesis-stimulating agents (ESAs) in chronic renal failure (CRF). TREAT is a large, randomized, double-blind, placebo-controlled Phase 3 study of patients with moderate kidney dysfunction who were not on dialysis, had moderate anemia and type-2 diabetes and were treated to a hemoglobin target of 13 g/dL.

Amgen has a deep commitment to patient safety and quality patient care and looks forward to joining the FDA and members of the nephrology community, including physicians and patients, to discuss the appropriate use of ESAs in CRF patients informed by the TREAT results.

Indication:

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia associated with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.

Important Safety Information, including Boxed WARNINGS:

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

  • In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp® (darbepoetin alfa) to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.
  • Aranesp® is contraindicated in patients with uncontrolled hypertension.
  • Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
  • These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
  • A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®.
    • This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
    • A sudden loss of response to Aranesp®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
    • If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp® and other ESAs. Aranesp® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
  • Seizures have occurred in patients with CRF participating in Aranesp® clinical trials.
  • The most commonly reported side effects in clinical trials in patients with CRF were infection, hypertension, hypotension, and muscle spasm.

Contact:
Emma Hurley, 202-585-9647 (media)
Arvind Sood, 805-447-1060 (investors)

 

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