Amgen in Discussions with FDA to Update U.S. Prescribing Information for ESAs
Revised ESA Labeling to be Based on New Data from PREPARE and GOG
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 6, 2007--Amgen Inc.
(NASDAQ:AMGN) today announced the company is in discussions with the
U.S. Food and Drug Administration (FDA) with the goal of updating
safety information in all erythropoiesis-stimulating agents (ESAs)
labeling based on safety data from the recently announced PREPARE
interim study results in neoadjuvant breast cancer and the recently
published follow up data from the Gynecologic Oncology Group (GOG)
study in cervical cancer. While Amgen's interactions with the FDA are
ongoing and exact language for the updated labeling is not final, the
company is committed to providing timely and appropriate
communications to patients and physicians.
Amgen and the FDA are discussing the label changes under the
regulatory mechanism known as a "changes being effected" (CBE)
process. Additionally, Amgen has been advised there will be an
Oncologic Drugs Advisory Committee (ODAC) meeting in the first quarter
of 2008 as part of the ongoing pharmacovigilance review of ESA
therapies. Decisions around the precise timing of this ODAC meeting
will not be finalized until publication by the FDA in the Federal
"The PREPARE and GOG studies were off-label, high-hemoglobin
target studies that contain important information relevant to specific
patient populations receiving ESAs," said Roger M. Perlmutter, M.D.,
Ph.D., executive vice president of Research and Development at Amgen.
"As new information, including additional study results, becomes
available, Amgen will communicate the data and, where appropriate,
work with the FDA to update our product labels."
Additional information about the PREPARE and GOG studies is
available at www.amgen.com.
Aranesp was approved by the FDA in September 2001 for the
treatment of anemia associated with chronic renal failure (CRF) for
patients on dialysis and patients not on dialysis. In July 2002, the
FDA approved weekly dosing of Aranesp for the treatment of anemia
caused by concomitantly administered chemotherapy in patients with
nonmyeloid malignancies and in March 2006, the FDA approved
every-three-week dosing in these patients.
Important Aranesp Safety Information
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and
THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and
serious cardiovascular events when administered erythropoiesis-
stimulating agents (ESAs) to target higher versus lower hemoglobin
levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies.
Individualize dosing to achieve and maintain hemoglobin levels within
the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or time-to-tumor progression in
clinical studies in patients with advanced breast, head and neck,
lymphoid, and non-small cell lung malignancies when dosed to target a
hemoglobin of greater than or equal to 12 g/dL.
-- The risks of shortened survival and tumor progression have not been
excluded when ESAs are dosed to target a hemoglobin of less than 12
-- To minimize these risks, as well as the risk of serious cardio- and
thrombovascular events, use the lowest dose needed to avoid red blood
-- Use only for treatment of anemia due to concomitant
-- Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled
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With a deep and broad pipeline of potential new medicines, Amgen
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people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in our Form 10-K for the year ended Dec.
31, 2006, and in our periodic reports on Form 10-Q and Form 8-K. Amgen
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CONTACT: Amgen, Thousand Oaks
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.