New Boxed Warning Applies to Oncology and Nephrology Indications for the Class of Approved ESAs
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 9, 2007--Amgen
(NASDAQ:AMGN) today announced the U.S. Food and Drug Administration
(FDA) has approved updated safety information, including a boxed
warning in the prescribing information for the class of drugs known as
Erythropoiesis-stimulating Agents (ESAs), including Aranesp(R)
(darbepoetin alfa) and EPOGEN(R) (Epoetin alfa).
"Patient safety is unquestionably our top priority. Amgen is
committed to providing timely and appropriate communications to
physicians and patients whenever we become aware of new safety
information that could affect clinical practice," said Roger M.
Perlmutter, M.D., Ph.D., executive vice president of Research and
Development at Amgen.
Updated information for patients in the revised label notes that
"patients should be informed of the increased risks of mortality,
serious cardiovascular events, thromboembolic events, and tumor
progression when used in off-label dose regimens or populations."
The new boxed warning notes that ESAs, when administered to target
a hemoglobin of greater than 12 g/dL:
-- Increased the risk for death and for serious cardiovascular
-- Shortened the time to tumor progression in patients with
advanced head and neck cancer receiving radiation therapy; and
-- Shortened overall survival and increased deaths attributed to
disease progression at four months in patients with metastatic
breast cancer receiving chemotherapy.
Cardiovascular events and tumor progression have been moved to the
"Warnings" section from the "Precautions" section of all ESA labels.
The new boxed warning also states that ESAs increased the risk of
death when administered to target a hemoglobin of 12 g/dL in patients
with active malignant disease receiving neither chemotherapy nor
radiation therapy. ESAs are not indicated for this population. In
addition, for patients receiving ESAs pre-operatively for reduction of
allogeneic blood transfusions, a higher incidence of deep venous
thrombosis was documented in patients receiving Epoetin alfa who were
not receiving prophylactic anticoagulation. Aranesp is not approved
for this indication.
"The boxed warning includes information from several
investigational studies that were previously communicated to the
medical community," added Dr. Perlmutter. "The vast majority of
oncologists and nephrologists do not appear to be maintaining Hb
levels above 12 g/dL in approved indications."
Physicians are advised in the boxed warning and "Dosing and
Administration" section to use the lowest dose of ESAs that will
gradually increase the hemoglobin concentration to the lowest level
sufficient to avoid the need for red blood cell transfusions, and not
to exceed 12 g/dL. Additional dosing information for cancer patients
has been updated in the "Dosage and Administration" section of the
prescribing information, including new dosing adjustment and
withholding guidelines to keep hemoglobin levels from exceeding 12
Amgen is informing healthcare professionals about the revisions to
the U.S. prescribing information through a joint "Dear Healthcare
Professional" letter with Ortho Biotech and will post the letter and
updated prescribing information on Amgen´s Web site, www.amgen.com.
Amgen is committed to broadly disseminating this important new
prescribing information so that prescribers are informed about the
safety of ESAs. Over the coming weeks, our field force will be calling
on healthcare professionals to communicate this important new safety
The FDA is planning to review the safety and efficacy of ESAs at
an upcoming meeting of the FDA´s Oncologic Drugs Advisory Committee
(ODAC) on May 10, 2007. Amgen is fully committed to participating in
this expert review of the safety and efficacy of ESAs.
The indications for Aranesp and EPOGEN have not changed. Aranesp
is indicated for the treatment of chemotherapy-induced anemia and
anemia associated with chronic kidney disease (CKD), for patients on
dialysis and patients not on dialysis. EPOGEN is indicated for the
treatment of anemia associated with CKD, for patients on dialysis.
Amgen always recommends that physicians and other prescribers
carefully follow FDA-approved prescribing instructions.
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s promise by bringing safe,
effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
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With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people´s lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
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Trish Hawkins, 805-447-5631 (media, oncology)
Dan Whelan, 805-447-5995 (media, nephrology)
Arvind Sood, 805-447-1060 (investors)