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Monday 27th March, 2006
FDA has approved every-3-week dosing of
Aranesp (darbepoetin alfa) for treatment of
chemotherapy - induced anemia.
THOUSAND OAKS, Calif., (March 27, 2006) ? Amgen (NASDAQ:
AMGN), the world's largest biotechnology company, today
announced the U.S. Food and Drug Administration (FDA) has
approved every-three-week dosing of Aranesp? (darbepoetin alfa)
for the treatment of chemotherapy-induced anemia (low red blood
cell count) in patients with non-myeloid malignancies. Aranesp
is the only erythropoiesis-stimulating agent approved by the FDA
for every-three-week administration.
"Amgen developed Aranesp to provide cancer patients with a
long-acting and effective means to treat chemotherapy-induced
anemia, a common side effect of chemotherapy," said Willard Dere,
M.D., chief medical officer and senior vice president of Global
Development at Amgen. "The approval of an extended dosing
protocol for Aranesp is an important milestone allowing anemia
treatment to be synchronized with both weekly and
every-three-week chemotherapy, which are the most commonly used
treatment regimens. This offers improved convenience for
patients and less injection-related burden for patients and
healthcare professionals compared to weekly anemia treatment."
Anemia can negatively affect patients and impact their daily
activities. This can often manifest as fatigue, trouble
breathing or rapid heartbeat, chest pain, dizziness or
lightheadedness, inability to concentrate, headache, inability
to stay warm, loss of sex drive, and pale skin. Frequent visits
to the clinic for anemia treatment can result in significant
time spent by patients, caregivers and healthcare providers.
Reducing the number of visits required for anemia treatment with
less frequent dosing and trying to synchronize anemia treatment
with other naturally occurring visits could reduce the amount of
patient and caregiver time required for anemia treatment.
"In clinical studies, Aranesp has proven effective in
reducing the incidence of red blood cell transfusions and
boosting and maintaining target hemoglobin levels when
administered every three weeks," said Ralph Boccia, M.D.,
director of clinical research, Center for Cancer and Blood
Disorders, Bethesda, MD. "Now, this less frequent dosing means
patients can visit the doctor less frequently, which can result
in less time away from loved ones and daily activities."
The update to the Aranesp label now includes a recommended
starting dose of 500 mcg once every three weeks in addition to
the recommended starting dose of 2.25 mcg/kg once weekly. The
new dosing recommendations are based on a randomized,
double-blind, phase 3 study that evaluated the safety and
effectiveness of every-three-week administration of Aranesp.
Patients with chemotherapy-induced anemia were randomized to
receive 500 mcg of Aranesp every three weeks (n=353) or 2.25
mcg/kg (n=352) administered weekly for up to 15 weeks. In both
groups, the starting dose was reduced by 40 percent if
hemoglobin levels increased by more than 1 g/dL in a 14-day
period, and Aranesp was withheld if hemoglobin levels exceeded
13 g/dL. More than 70 percent of patients in the
every-three-week group required dose reductions, resulting in an
average weekly dose of 125 mcg for the patients in this group.
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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 chemotherapy
patients report that fatigue, a common symptom of anemia,
affects their daily lives more than any other side effect of
treatment, including nausea, pain and depression.
Although anemia is one of the most common side effects of
chemotherapy, it is often not recognized and frequently
under-treated, despite treatments that have been available for
more than a decade. In fact, approximately half of patients with
a hemoglobin level less than the recommended target level of 11
to 12 g/dL in the National Comprehensive Cancer Network? (NCCN)
guidelines for "Cancer and Treatment-Related Anemia" are never
treated with erythropoietic therapy.
Amgen revolutionized anemia treatment with the development of
Epoetin alfa, a recombinant erythropoietin (a protein that
stimulates the production of oxygen-carrying red blood cells).
Building on this heritage, Amgen developed Aranesp, a unique
erythropoiesis-stimulating protein that can be dosed less
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia associated
with chronic renal failure (CRF), also known as chronic kidney
disease (CKD), for patients on dialysis and patients not on
dialysis. In July 2002, Aranesp was approved by the FDA for the
treatment of chemotherapy-induced anemia in patients with
nonmyeloid malignancies. Since it's introduction in 2001, more
than 1.7 million CKD and chemotherapy patients with anemia have
received treatment with Aranesp.
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 2-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.
Cases of pure red cell aplasia (PRCA) and of severe anemia,
with or without other cytopenias associated with neutralizing
antibodies to erythropoietin have been reported in patients
treated with Aranesp. This has been reported predominately in
patients with CRF receiving Aranesp by subcutaneous
administration. A sudden loss of response to Aranesp,
accompanied by severe anemia and low reticulocyte count, should
be evaluated. If anti-erythropoietin antibody-associated anemia
is suspected, withhold Aranesp and other erythropoietic
proteins. Aranesp should be permanently discontinued in patients
with antibody-mediated anemia. Patients should not be switched
to other erythropoietic proteins.
The most commonly reported side effects in clinical trials
were fatigue, edema, nausea, vomiting, diarrhea, fever, and