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EDTA removed from liquid formulation / Restoration of U.S. supplies of Leukine
Berlin, May 19, 2008 - Bayer HealthCare announced today that a reformulation of
the liquid Leukine® (sargramostim) 500 mcg vial has been approved by the United
States Food and Drug Administration (FDA) and is now available for patients and
physicians in the U.S. The new formulation does not contain EDTA (edetate
disodium), which was used in the product's liquid 500 mcg vial manufactured
from January 2006 to January 2008. In January 2008, Bayer withdrew the
previously marketed liquid Leukine 500 mcg vial from the U.S. market, because
of an increase in spontaneous reporting of certain labeled adverse events,
including syncope (fainting). The timing of increased reporting of these
adverse events coincided with the change in the formulation of liquid Leukine
to include EDTA in 2006.
"We are pleased to bring back to U.S. oncologists and hematologists an
EDTA-free formulation of liquid Leukine for the care of their patients," said
Dr. Gunnar Riemann, member of the Executive Committee of Bayer HealthCare. "At
Bayer, providing effective and safe medicines for patients is our highest
priority." Leukine has been used to treat nearly 350,000 cancer patients in the
U.S. since 1991. New data will be reported at the upcoming American Society for
Clinical Oncology (ASCO) conference regarding the clinical impact of Leukine in
cancer care.
Among its indications, Leukine is the only myeloid growth factor approved to
reduce the incidence of severe and life-threatening infections and infections
resulting in death following induction chemotherapy in older adult patients
with acute myelogenous leukemia (AML) and to prolong survival of patients who
have undergone allogeneic or autologous bone marrow transplantation (BMT) and
are experiencing graft failure or engraftment delay, as compared to historical
experience. With the approval and relaunch of liquid Leukine in a non-EDTA
formulation, Bayer is closing a special access program that reserved priority
access to lyophilized Leukine 250 mcg vials, which does not contain EDTA, for
patients with the greatest medical need. Sufficient supply of the new, 'non-
EDTA' liquid formulation and lyophilized Leukine is now available to meet
cancer care market demand.
About Leukine®
Leukine® (sargramostim) is a growth factor that helps fight infection and
disease in appropriate patients by enhancing immune cell function. Leukine was
approved in the United States in 1991, and is marketed by Bayer HealthCare
Pharmaceuticals. Leukine is the only growth factor approved in the US for use
following induction chemotherapy in older adults with acute myelogenous
leukemia (AML) to shorten the time to neutrophil recovery and reduce the
incidence of severe and life-threatening infections and infections resulting in
death. Leukine also has been approved in the US for use in four additional
indications: myeloid reconstitution following allogeneic and autologous bone
marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization
and subsequent myeloid reconstitution in patients undergoing PBSC
transplantation, and bone marrow transplantation failure or engraftment delay.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
