Amgen Submits Supplemental Biologics License Application for Aranesp Extended Dosing; Phase 3 Study Evaluated Aranesp Dosed Once Every Three Weeks in Patients with Chemotherapy-Induced Anemia
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--May 6, 2005--Amgen Inc.
(Nasdaq:AMGN), the world's largest biotechnology company, today
announced the submission of a supplemental Biologics License
Application (sBLA) to the U.S. Food and Drug Administration (FDA) for
Aranesp(R) (darbepoetin alfa). The sBLA is based on Phase 3 data that
Amgen believes will demonstrate Aranesp administered every three weeks
is safe and effective in the treatment of chemotherapy-induced anemia
in patients with non-myeloid malignancies. If approved, Aranesp will
be the first therapy indicated in the United States for once every
three week dosing in the treatment of anemia in these patients.
"As the first company to clone erythropoietin and develop
recombinant EPO as a therapy, Amgen is deeply committed to improving
the chemotherapy experience for cancer patients and their families,"
said Willard Dere, M.D., chief medical officer and senior vice
president of global development at Amgen. "Since chemotherapy is most
commonly given to patients every three weeks, an extended dosing
schedule for Aranesp has the potential to reduce the amount of
patient, physician and caregiver time required for anemia therapy."
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 (Hb) level less than
the recommended target level of 11 to 12 g/dL in the National
Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and
Treatment-Related Anemia" are never treated with erythropoietic
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
United States by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho
Biotech Products, LP, 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 (CKD).
Aranesp is approved for multiple indications with varying dosage
instructions in both the United States and in Europe. 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
Important Safety Information
Aranesp(R) 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.
Pure red cell aplasia (PRCA) has been observed in patients treated
with recombinant erythropoietins. This has been reported predominantly
in patients with CRF. Aranesp(R) 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.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in Amgen's Form 10-K for the year ended
December 31, 2004, and in Amgen's periodic reports on Form 10-Q and
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Healthcare professionals should refer to and rely upon the
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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 Products,
CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.