Aranesp Dosed Every Three Weeks Achieved and Maintained Target Hemoglobin Levels in Patients with Chemotherapy-Induced Anemia
ORLANDO, Fla.--(BUSINESS WIRE)--May 15, 2005--Amgen Inc.,
(NASDAQ:AMGN) the world's largest biotechnology company, today
announced that new interim data from a single-arm, open label study of
1,225 cancer patients receiving chemotherapy demonstrated that
Aranesp(R) (darbepoetin alfa) administered every three weeks was
effective in increasing and maintaining patient hemoglobin levels to
the recommended target of greater than or equal to 11 g/dL. Further,
treatment with Aranesp reduced the need for red blood cell
transfusions in cancer patients with chemotherapy-induced anemia. The
results of the study were presented at the 41st Annual Meeting of the
American Society of Clinical Oncology (ASCO). (Abstract #8129)
"Chemotherapy is most often administered every three weeks. Our
results suggest that every-three-week dosing of Aranesp at 300 mcg may
allow physicians to effectively combine anemia treatment on the same
schedule as chemotherapy," said Ralph Boccia, M.D., clinical associate
professor of medicine, Georgetown University Medical Center. "This may
improve patient convenience without sacrificing efficacy."
In the interim analysis of 1,225 cancer patients receiving 300 mcg
of Aranesp every three weeks, 91 percent of patients achieved a target
hemoglobin of greater than or equal to 11 g/dL, and 72 percent of
patients maintained the target hemoglobin level. The mean hemoglobin
was 11.5 g/dL after achieving target hemoglobin. From week five to the
end of the study (week 16), only 20 percent of patients required red
blood cell transfusion.
The number and type of adverse events were consistent with the
adverse event profile for this population of anemic cancer patients
In May, Amgen announced submission of a supplemental biologics
license application to the U.S. Food and Drug Administration (FDA) for
every-three-week dosing of Aranesp for the treatment of
chemotherapy-induced anemia in patients with non-myeloid malignancies.
Final results from a Phase 3 head-to-head study of Aranesp 200 mcg
administered every two weeks and Epoetin alfa dosed once a week were
also presented during the ASCO Annual Meeting. (Abstract #8125)
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red
blood cells that transport oxygen from the lungs to all of the body's
muscles and organs. Anemia occurs when there are too few red blood
cells and the body's tissues are "starved" of oxygen, which can make a
patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo
chemotherapy in the United States; approximately 800,000 (67 percent)
will become anemic. More than half of these patients report that
fatigue associated with anemia affects their daily lives more than any
other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of
chemotherapy, it is often not recognized and frequently under-treated.
In fact, 42 percent of patients with a hemoglobin level less than the
recommended target level of 11 g/dL in the National Comprehensive
Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related
Anemia" are never treated with erythropoietic therapy.
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized anemia treatment with the development of recombinant
erythropoietin, Epoetin alfa, which is currently marketed in the U.S.
by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products,
L.P., as Procrit(R) (Epoetin alfa)(ii). Building on this heritage,
Amgen developed Aranesp, a unique erythropoiesis stimulating protein,
which contains two additional sialic acid-containing carbohydrate
chains than the Epoetin alfa molecule and remains in the bloodstream
longer than Epoetin alfa because it has a longer half-life. By virtue
of its longer half-life, Aranesp should be administered less
frequently than Epoetin alfa in patients with chronic kidney disease
Aranesp is approved for multiple indications with varying dosage
instructions in the U.S., European Union, Canada and Australia.
Aranesp was approved by the FDA in September 2001 for up to
every-two-week dosing for the treatment of anemia associated with
chronic renal failure, also known as CKD, for patients on dialysis and
patients not on dialysis. In July 2002, Aranesp was approved by the
FDA for weekly dosing for the treatment of chemotherapy-induced anemia
in patients with non-myeloid malignancies. In 2004, the European
Committee for Medicinal Products for Human Use approved Aranesp for
extended dosing intervals of once every three weeks in the treatment
of anemia in adult cancer patients with non-myeloid malignancies who
are receiving chemotherapy and monthly in the treatment of anemia
associated with CKD.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic events, and other serious events. The target hemoglobin
(Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in
any two-week period, dose reductions are recommended. In a study with
another erythropoietic product, where the target Hb was 12-14 g/dL, an
increased incidence of thrombotic events, disease progression and
mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated
with recombinant erythropoietins. This has been reported predominantly
in patients with chronic renal failure. Aranesp should be discontinued
in any patient with evidence of PRCA and the patient evaluated for the
presence of antibodies to erythropoietin products. The most commonly
reported side effects in clinical trials were fatigue, edema, nausea,
vomiting, diarrhea, fever and dyspnea.
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Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging on to www.aranesp.com.
(i) Epogen(R) is a registered trademark of Amgen Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech
Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.