Reformulated Liquid Leukine® Now Available in the U.S.
EDTA removed from liquid formulation / Restoration of U.S. supplies of Leukine
Berlin, May 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.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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