Revised Boxed Warning Applies to Oncology Indication for the Class of Approved ESAs
THOUSAND OAKS, Calif., Mar 07, 2008 (BUSINESS WIRE) -- Amgen Inc. (NASDAQ:AMGN) today announced the U.S. Food and Drug
Administration (FDA) has approved updated safety information,
including an updated boxed warning in the labeling information for the
class of drugs known as erythropoiesis-stimulating agents (ESAs),
including Aranesp(R) (darbepoetin alfa) and EPOGEN(R) (Epoetin alfa).
The updated boxed warning states that ESAs shortened overall
survival and/or time-to-tumor progression in clinical studies in
patients with breast, non-small cell lung, head and neck, lymphoid and
cervical cancers, when dosed to target a hemoglobin of greater than or
equal to 12 g/dL.
In the "Increased Mortality and/or Tumor Progression" warning
section of the updated labeling, the interim results of the
Preoperative Epirubicin Paclitaxel Aranesp (PREPARE) study in
neo-adjuvant breast cancer were added as well as follow up data from
the Gynecologic Oncology Group study in cervical cancer.
Amgen and Johnson & Johnson have submitted all available clinical
data to the FDA including the data from these two study studies now
reflected in the product labeling, as well as data from other
informative controlled clinical studies with ESAs in the oncology
setting. In general, these results have not changed the benefit-risk
profile significantly of ESAs in this setting from previously
available data discussed at the May 4, 2004, and May 10, 2007,
Oncologic Drugs Advisory Committee (ODAC) meetings. Amgen will address
the science and safety of ESAs in oncology, including these new data,
at an upcoming ODAC meeting next week on Thursday, March 13, 2008.
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 along
with the updated prescribing information on Amgen´s Web site,
"Amgen is committed to ensuring physicians and patients have the
latest information about ESAs in order to make appropriate treatment
decisions," said Sean Harper, Amgen´s Chief Medical Officer. "Last
year, we communicated the new safety information in several ways,
including disseminating DHCP letters, posting the new labeling on our
Web site, focusing promotional activity from March until the May ODAC
on warnings and safety data, and hosting ongoing briefings with the
Amgen´s ongoing risk management activities includes working with
the FDA to design additional pharmacovigilance studies to address
safety concerns around ESAs, developing a patient medication guide to
communicate the benefit/risk of ESAs, and continuing to publicly
communicate updates on ESAs to the public and oncology community.
Important Aranesp and EPOGEN 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 breast,
non-small cell lung, head and neck, lymphoid, and cervical
cancers 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 g/dL.
-- To minimize these risks, as well as the risk of serious
cardio- and thrombovascular events, use the lowest dose needed
to avoid red blood cell transfusions.
-- Use only for treatment of anemia due to concomitant
-- Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled
Amgen discovers, develops, manufacturers 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 and 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, kidney disease, rheumatoid arthritis, and other
serious illnesses. 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.
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, 2007, and in our periodic reports on Form 10-Q and Form 8-K. Amgen
is providing this information as of the date of this news release and
does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information,
future events or otherwise.
No forward-looking statement can be guaranteed and actual results
may differ materially from those we project. The Company´s results may
be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments (domestic or foreign) involving current and
future products, sales growth of recently launched products,
competition from other products (domestic or foreign) and difficulties
or delays in manufacturing our products. In addition, sales of our
products are affected by reimbursement policies imposed by third-party
payors, including governments, private insurance plans and managed
care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward
managed care and health care cost containment as well as U.S.
legislation affecting pharmaceutical pricing and reimbursement.
Government and others´ regulations and reimbursement policies may
affect the development, usage and pricing of our products.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. We or others could identify safety,
side effects or manufacturing problems with our products after they
are on the market. Our business may be impacted by government
investigations, litigation and product liability claims. Further,
while we routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors. We depend
on third parties for a significant portion of our manufacturing
capacity for the supply of certain of our current and future products
and limits on supply may constrain sales of certain of our current
products and product candidate development. In addition, we compete
with other companies with respect to some of our marketed products as
well as for the discovery and development of new products. Discovery
or identification of new product candidates cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can
be no guarantee that any particular product candidate will be
successful and become a commercial product. Further, some raw
materials, medical devices and component parts for our products are
supplied by sole third-party suppliers.
SOURCE: Amgen Inc.
Amgen, Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)