Analysis of Head-to-Head Studies Shows That Aranesp(R) Dosed Every Two Weeks Offers Similar Results With Less Frequent Administration Compared to Epoetin Alfa
These results support the recently published National Comprehensive Cancer
Network Guidelines on Cancer and Treatment Related Anemia
SAN DIEGO, Dec. 7 - Amgen (Nasdaq: AMGN), the
world's largest biotechnology company, today presented data from head-to-head
trials suggesting that Aranesp (darbepoetin alfa) dosed 200 mcg once every two
weeks provided similar results to epoetin alfa dosed 40,000 units once weekly
in boosting hemoglobin and reducing the need for blood transfusions in cancer
patients undergoing chemotherapy. The results were presented by the study's
lead investigator, Dr. Lee Schwartzberg, medical director of The West Clinic,
Memphis, Tenn., at the American Society of Hematology (ASH) Annual Meeting.
"This analysis should provide the oncology community with further trial
data that Aranesp can treat anemia and offer the benefit of less frequent
dosing. Fewer injections can translate into less office visits, which is a
meaningful benefit for patients and caregivers. Studies have shown that, on
average, a simple injection requires two or more hours of a patient's day and
more than an hour of a caregiver's day," said Schwartzberg.
The interim analysis evaluated the first 210 patients enrolled in three
identical, randomized, open-label, multi-centered studies in patients with
breast, lung, and gynecologic cancers. Patients in both arms of the studies
had similar hemoglobin responses, hematopoietic responses, transfusion rates
and mean change in hemoglobin. In addition, the results were analyzed based
upon the outcome hemoglobin targets defined within the new National
Comprehensive Cancer Network (NCCN) guidelines on cancer and treatment-related
The NCCN guidelines set an important standard for clinical oncology
practice stating that physicians should initiate therapy when hemoglobin is
less than 11 g/dL and target treatment to maintain patients' hemoglobin
between 11-12 g/dL for optimal care. These guidelines are the first to
recognize the use of Aranesp dosed at 200 mcg every other week.
More than 90 percent of Aranesp patients in the analysis reached the NCCN
guideline target range (11-12g/dL) and almost all of the patients were
maintained successfully. The time to reaching target range was comparable in
both treatment groups. Further studies to confirm these findings are planned.
For the analysis, there were 105 patients in each arm with a mean baseline
hemoglobin of 10.4 g/dL. The mean change in hemoglobin after 17 weeks of
treatment was similar between the treatment groups (1.4 g/dL for the Aranesp
group and 1.5 g/dL for the epoetin alfa group, using the intent-to-treat
approach (missing values or values within 28 days of a transfusion were
imputed using the last-value-carried-forward method)). No difference in the
incidence of severity of adverse events was observed between treatment groups.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in
July 2002 for the treatment of chemotherapy-induced anemia in patients with
nonmyeloid malignancies. Aranesp was approved by the FDA in September 2001
for the treatment of anemia associated with chronic renal failure, also known
as chronic kidney disease, for patients on dialysis and patients not on
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,
which is currently marketed in the U.S. by Amgen as EPOGEN(R)(i) and by Ortho
Biotech Products, LP, as Procrit(R) (ii). Building on this heritage, Amgen
developed Aranesp, which contains two additional sialic acid-containing
carbohydrate chains than the Epoetin alfa molecule resulting in more activity
with the added benefit of less-frequent administration.
Aranesp is contraindicated in patients with uncontrolled hypertension.
Erythropoietic therapies may increase the risk of thrombotic and other serious
events; dose reductions are recommended if the hemoglobin increase exceeds 1.0
g/dL in any two-week period. The most commonly reported side effects in
Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and
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Aranesp prescribing information can be accessed by calling 800-772-6436 or
by logging onto www.aranesp.com.
CONTACT: Amgen, Thousand Oaks
Kelly Stoddard, (805) 447-0821 (media)
Cary Rosansky, (805) 447-1060 (investors)
(i) EPOGEN(R) is a registered trademark of Amgen Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.
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