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Bayer Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid Formulation
Date:1/23/2008

Patient safety is Bayer's primary concern and we will continue to work closely with the FDA to address this issue. Leukine has been used to treat nearly 350,000 patients in the US since 1991 and remains an important therapeutic option for many patients.

About Leukine(R)

Leukine(R) (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the US 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.

Patients taking Leukine may experience some side effects, most of which are mild to moderate. In controlled clinical trials across all indications, no significant differences were observed between Leukine and placebo-treated patients in the type or frequency of adverse events with the exception of an increase in skin-associated events in the Leukine group in the pivotal AML trial. There were occasional reports of fluid retention, dyspnea (labored breathing), supraventricular tachycardia (accelerated heart rate), and laboratory abnormalities (increases in creatinine, bilirubin, and liver enzymes). Other adverse events have been reported. For full prescribing information, please visit http://www.pharma.bayer.com.

About Bayer HealthCare Pharm
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
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