Amgen (NASDAQ:AMGN) today announced that the European Medicines
Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP)
has communicated to Marketing Authorization Holders (MAHs) of epoetins
a proposal for amending prescribing information for Erythropoiesis
Stimulating Agents (ESAs) in the European Union, including Aranesp(R)
(darbepoetin alfa).
The CHMP's proposal includes:
-- Amending the Summaries of Product Characteristics (SmPCs) for
all approved ESAs to stipulate a uniform target hemoglobin
range for all epoetins of 10 g/dL to 12 g/dL with guidance to
avoid sustained hemoglobin levels above 12 g/dL.
-- Providing guidance for dosage adjustments to maintain
hemoglobin concentration between 10-12 g/dL.
-- Amending the Special Warnings to explain that trials have
shown an unexplained excess mortality in association with high
target hemoglobin concentrations (greater than 12 g/dL).
-- Amending the Special Warnings to say that epoetins have not
been shown to improve overall survival or the risk of tumor
progression in patients with anemia associated with cancer.
-- Amending the therapeutic indication for chronic renal failure
(CRF) from "treatment of anemia associated with CRF" to
"treatment of symptomatic anemia associated with CRF" in adult
and pediatric patients.
The proposed amendments are not final and Amgen will continue
discussions with EMEA to finalize the language and update product
labeling accordingly. Over the coming weeks Amgen will also advise
prescribing health care professionals of the appropriate changes in
the form of a Dear Health Care Professional (DHCP) Letter. Final
approved prescribing information is expected in early 2008.
About Aranesp
Aranesp was granted marketing authorization by the European
Commission in 2001 for the treatment of anemia associated with chronic
renal failure (CRF), in adults and pediatric subjects 11 years of age
or older. In 2002, the European Commission approved Aranesp for the
treatment of anemia in adult cancer patients receiving chemotherapy
with solid tumors. This patient population was subsequently expanded
in 2003 to include treatment of symptomatic anemia in adult cancer
patients with non-myeloid malignancies receiving chemotherapy.
Approval was granted in 2004 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 up to once-per-month Aranesp administration in the treatment of
anemia in chronic kidney disease (CKD) patients not on dialysis. In
2006, the Aranesp label was updated to allow CKD patients on dialysis
to switch from rHuEPO one to three times a week to Aranesp every two
weeks. In 2007, the Aranesp label was updated to allow for treatment
of anemia associated with CRF, in all European pediatric patients on
dialysis or not on dialysis.
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia associated with
CRF for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
anemia caused by concomitantly administered chemotherapy in patients
with nonmyeloid malignancies and in March 2006, the FDA approved
every-three-week dosing in these patients.
Important EU Aranesp Safety Information
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic and other serious events; regional guidelines should be
referred to for target and maximum hemoglobin levels, and dose
adjustment rules should be performed in line with regional prescribing
information.
The most commonly reported side effects in clinical trials were
arthralgia, edema, injection site pain, and thromboembolic event
reactions. Prescribers are recommended to consult regional prescribing
information before prescribing Aranesp, including side-effects,
precautions and contra-indications.
Important U.S. Aranesp Safety Information
Use the lowest dose of Aranesp(R) that will gradually increase the
hemoglobin concentration to the lowest level sufficient to avoid the
need for red blood cell transfusion.
Aranesp(R) and other erythropoiesis-stimulating agents (ESAs)
increased the risk for death and for serious cardiovascular events
when administered to target a hemoglobin of greater than 12 g/dL
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with
advanced head and neck cancer receiving radiation therapy when
administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic
breast cancer receiving chemotherapy when administered to
target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when administered to target a
hemoglobin of 12 g/dL in patients with active malignant
disease receiving neither chemotherapy or radiation therapy.
ESAs are not indicated for this population.
Patients receiving ESAs pre-operatively for reduction of
allogeneic red blood cell transfusions: A higher incidence of deep
venous thrombosis was documented in patients receiving Epoetin alfa
who were not receiving prophylactic anticoagulation. Aranesp(R) is not
approved for this indication.
Aranesp is contraindicated in patients with uncontrolled
hypertension.
About Amgen
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science's promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis and other serious illnesses. With
a deep and broad pipeline of potential new medicines, Amgen remains
committed to advancing science to dramatically improve people's lives.
To learn more about our pioneering science and our vital medicines,
visit www.amgen.com.
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