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Bayer HealthCare Pharmaceuticals (BAY) Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid Formulation


1/23/2008 8:12:42 AM

WAYNE, N.J., Jan. 23 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today, following consultation with the United States Food and Drug Administration (FDA), that it will withdraw the current liquid formulation of Leukine(R) marketed in the US. This decision was made in light of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with the liquid Leukine 500 mcg vial which currently contains EDTA (edetate disodium).

While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial which does not contain EDTA. The upward trend in adverse event reporting rates is only associated with the Leukine liquid 500 mcg vial containing EDTA. Bayer has not observed an upward trend in reporting rates of these adverse events in the marketed Leukine 250 mcg lyophilized vial which does not contain EDTA. These adverse reactions are listed in the Leukine prescribing information.

The special access program is designed to prioritize the supply of the lyophilized Leukine for patients with Acute Myelogenous Leukemia (AML) and those who are experiencing bone marrow transplantation engraftment failure or delay. Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML and to prolong survival of patients with bone marrow graft failure or engraftment delay, as compared to historical experience. The special access program also will be used to provide continued Leukine therapy to patients currently participating in ongoing clinical studies.

Bayer informed the FDA of an increase in reporting rates of syncope, with or without documented hypotension; these adverse reactions are listed in the Leukine prescribing information. The timing of increased reporting of these adverse events coincides with a change in the formulation of liquid Leukine to include EDTA.

Bayer has posted a Dear Health Care Provider letter, along with its enclosures, on its websites today at www.pharma.bayer.com, www.bayeroncology.com and www.leukine.com and will be mailing it to U.S. oncologists and hematologists who prescribe and use Leukine for their patients.

In the coming days, Bayer will provide hematologists and oncologists who prescribe and use Leukine for their patients with instructions for accessing priority supplies of lyophilized Leukine 250 mcg vial. Bayer will work to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA) as quickly as possible.

As of today Bayer is withdrawing current stock and no longer accepting new orders for the current liquid Leukine formulation, and no existing orders will be shipped from our distribution centers. Bayer asks that all US wholesalers, hospitals, clinics and physician offices having current supplies of Leukine liquid 500 mcg vial containing EDTA return those to Bayer. Bayer will follow up with customers to work through the details of the return and file the appropriate paperwork to initiate reimbursement. If customers have questions regarding the return process they may call Bayer HealthCare Pharmaceuticals toll free at 1-888-84Bayer (1-888-842-2937).

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 www.pharma.bayer.com.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

CONTACT: Cathy Keck Anderson, +1-206-254-5438,
cathy.keck.anderson@bayer.com, or Meredith Fischer, +1-203-812-6485,
meredith.fischer.b@bayer.com, both of Bayer HealthCare Pharmaceuticals Inc.

Web site: http://www.pharma.bayer.com/
http://www.bayeroncology.com/
http://www.leukine.com/


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