New Data On Aranesp(R) Dosed Every Other Week In Anemic Chronic Kidney Disease Patients Presented At 35th Annual Meeting Of The American Society Of Nephrology
PHILADELPHIA, PA, November 3, 2002
- Amgen (Nasdaq: AMGN), the world's largest biotechnology company,
today announced results from a large study presented at the American
Society of Nephrology (ASN) evaluating the effectiveness of Aranesp(R)
(darbepoetin alfa) dosed once every other week for correcting anemia
in patients with chronic kidney disease (CKD) not on dialysis. In
this study, 96 percent of patients receiving Aranesp were able to
reach and maintain target hemoglobin levels.
"This large-scale study reinforces previous data
that demonstrated Aranesp's power to correct anemia in CKD patients,"
said Robert D. Toto, MD, University of Texas, Southwestern Medical
School, Dallas, TX, one of the study's lead investigators. "New
data continue to demonstrate Aranesp offers physicians and patients
a more simplified dosing schedule than existing therapies."
In the study, 608 CKD patients not receiving dialysis
received Aranesp once every other week. Of the 463 patients who
completed the 24-week study, 445 patients (96.1 percent) reached
study target hemoglobin levels (11.0-13.0 g/dL). The average time
to achieve hemoglobin response was 5.7 weeks. Adverse events were
consistent with those expected in CKD patients receiving erythropoietic
therapy. [ASN Abstract # 809; Toto et al.]
Aranesp Improves Health-Related Quality of Life
in Patients with CKD
A second study presented at ASN found that treatment of anemia with
Aranesp is associated with improvements in health-related quality
of life (HRQOL) in patients with CKD. The study, led by Ravi Thadhani,
MD, MPH, Massachusetts General Hospital, Boston, MA, examined the
change in HRQOL after treatment of anemia with Aranesp. In the 48
patients who completed the study, patients' questionnaire scores
increased after receiving treatment with Aranesp.
"We know that Aranesp is effective in raising
hemoglobin levels in CKD patients. This study demonstrates that
an increase in hemoglobin level translates into improved quality
of life for patients," said Dr. Thadhani. "The magnitude
of the observed improvements in quality of life is clinically meaningful
and shows the value of anemia treatment for CKD patients and its
impact on their lives."
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized anemia treatment with the discovery of recombinant
erythropoietin. Epoetin alfa, the first recombinant EPO product
is currently marketed as EPOGEN(R)
and Procrit(R). Building
on this heritage, Amgen designed Aranesp, which contains two additional
sialic acid-containing carbohydrate chains compared with Epoetin
alfa, resulting in an approximately three fold longer half-life
which affords the benefit of extended dosing intervals. Aranesp
requires fewer injections than treatment with Epoetin alfa.
Aranesp was approved by the US Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia related to chronic
renal failure (often referred to as chronic kidney disease) in patients
on dialysis and patients not on dialysis. It is also approved for
this indication in most European countries, Australia, New Zealand
and Canada. Aranesp was also approved in the US (July 2002) and European
Union (August 2002) for the treatment of chemotherapy-induced anemia
in patients with nonmyeloid malignancies.
In the nephrology setting, the most commonly reported
side effects in Aranesp trials were infection, hypertension, hypotension,
myalgia, headache, and diarrhea. Increases in hemoglobin greater
than approximately 1.0 g/dL during any 2-week period have been associated
with serious side effects. The individual dose of Aranesp should
be adjusted for each patient to achieve and maintain a target hemoglobin
not to exceed 12 g/dL. Aranesp is contraindicated in CKD patients
with uncontrolled hypertension.
Amgen is a global biotechnology company that discovers,
develops, manufactures and markets important human therapeutics
based on advances in cellular and molecular biology.
# # #
CONTACT: Amgen, Thousand Oaks
Michael Beckerich, 805/447-8925 (media)
Cary Rosansky, 805/447-4634 (investors)
Note: Copies of the study abstracts are available
upon request. Full prescribing information is available on the Web
for Aranesp at www.aranesp.com.
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