FDA Approves Amgen's Aranesp For Anemia Associated With Chemotherapy
THOUSAND OAKS, CA,
2002 -- Amgen (NASDAQ:AMGN),
the world's largest biotechnology
company, today announced that the U.S. Food and Drug Administration
(FDA) has approved Aranesp (darbepoetin alfa) for the treatment
of chemotherapy-induced anemia in patients with nonmyeloid malignancies.
Aranesp is a recombinant erythropoietic protein (proteins that stimulate
production of oxygen-carrying red blood cells) that requires fewer
injections than existing treatment.
Amgen revolutionized anemia treatment with the
discovery of recombinant human erythropoietin in 1984, which led
to the development of Epoetin alfa, currently marketed as
Building on this heritage, Amgen created Aranesp,
which was developed to simplify anemia
Aranesp maintains its level in the blood
approximately three times longer than Epoetin alfa, offering healthcare
providers the ability to treat anemia related to chemotherapy with
less-frequent dosing than the current standard of care.
Less-frequent dosing results in fewer injections for patients.
It allows patients and caregivers to spend less time scheduling
injection visits, and will free up physicians and nurses to attend
to other patients and work activity.
"Anemia can take a tremendous toll on patients undergoing chemotherapy,
often leaving them too weak to perform routine activities. In severe
cases, anemia can force doctors to interrupt chemotherapy regimens,"
said Robert E. Smith, Jr., M.D., president of South Carolina Oncology
Associates PA and an Aranesp investigator. "Aranesp not only
helps correct anemia and maintain hemoglobin levels during chemotherapy,
but also helps chemotherapy patients and their physicians overcome
barriers that can hinder the delivery of current anemia treatment,
notably the need for frequent office visits."
This year, an estimated 1.2 million cancer patients will undergo
cytotoxic chemotherapy in the United States; and approximately 800,000
(67%) will become anemic. Anemia is the shortage of oxygen-carrying
red blood cells that fuel body function. Patients undergoing chemotherapy
often suffer from anemia because chemotherapy not only attacks cancerous
cells, but other cells in the body as well, including red blood
cells. Aranesp stimulates the bone marrow to increase the
production of red blood cells and has been shown to result in a
clinically significant improvement of anemia associated with chemotherapy.
Before Aranesp, physicians were limited to treating anemia associated
with chemotherapy with frequent injections of Epoetin alfa or red
blood cell transfusions.
"Aranesp is an important development that will make it easier
for oncologists to treat their chemotherapy patients' anemia,"
said Amgen chairman and chief executive officer Kevin Sharer. "Joining
the once-per-chemotherapy-cycle dosed Neulasta (pegfilgrastim),
Aranesp's simplified dosing regimen represents Amgen's next generation
of powerful supportive care treatments for patients receiving chemotherapy.
With Aranesp and Neulasta, Amgen is helping physicians, nurses and
patients address two of the most serious complications of
Clinical studies showed that patients suffering from chemotherapy-related
anemia who received Aranesp consistently reached target hemoglobin
(red blood cell) levels. The studies showed Aranesp to be generally
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 dialysis.
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 dyspnea; no important
differences were observed between Aranesp and Epoetin alfa.
Neulasta was approved by the FDA in January 2002 for decreasing
the incidence of infection as manifested by febrile neutropenia
(neutropenia with fever) in patients with non-myeloid malignancies
receiving myelosuppressive anti-cancer drugs.
In clinical trials, the most common adverse event attributed to
Neulasta therapy following combination chemotherapy in patients
(n=465) with lymphoma and solid tumors was bone pain, reported in
26% of patients. The only serious adverse event not attributed to
underlying disease or chemotherapy was a case of hypoxia. While
not reported in patients receiving Neulasta, rare events of adult
respiratory distress syndrome, splenic rupture, and sickle cell
crisis have been reported in patients receiving the parent compound,
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances
in cellular and molecular biology.
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actual results may differ materially from current results expected
by Amgen. Amgen is providing this information as of July 22, 2002
and expressly disclaims any duty to update information contained
in this press release.
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Contact: Amgen, Thousand Oaks
Michael J. Beckerich, 805/447-8925 (media)
Cary Rosansky, 805/447-4634 (investors)