Revised Boxed Warning Applies to Oncology Indication for the Class of Approved ESAsTHOUSAND OAKS, Calif., Mar 07, 2008 (BUSINESS WIRE) -- Amgen Inc. (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved updated safety information, including an updated boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp(R) (darbepoetin alfa) and EPOGEN(R) (Epoetin alfa).
The updated boxed warning states that ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers, when dosed to target a hemoglobin of greater than or equal to 12 g/dL.
In the "Increased Mortality and/or Tumor Progression" warning section of the updated labeling, the interim results of the Preoperative Epirubicin Paclitaxel Aranesp (PREPARE) study in neo-adjuvant breast cancer were added as well as follow up data from the Gynecologic Oncology Group study in cervical cancer.
Amgen and Johnson & Johnson have submitted all available clinical data to the FDA including the data from these two study studies now reflected in the product labeling, as well as data from other informative controlled clinical studies with ESAs in the oncology setting. In general, these results have not changed the benefit-risk profile significantly of ESAs in this setting from previously available data discussed at the May 4, 2004, and May 10, 2007, Oncologic Drugs Advisory Committee (ODAC) meetings. Amgen will address the science and safety of ESAs in oncology, including these new data, at an upcoming ODAC meeting next week on Thursday, March 13, 2008.
Amgen is informing healthcare professionals about the revisions to the U.S. prescribing information through a joint "Dear Healthcare Professional" letter with Ortho Biotech and will post the letter along with the updated prescribing information on Amgen's Web site, www.amgen.com.
"Amgen is committed to ensuring physicians and patients have the latest information about ESAs in order to make appropriate treatment decisions," said Sean Harper, Amgen's Chief Medical Officer. "Last year, we communicated the new safety information in several ways, including disseminating DHCP letters, posting the new labeling on our Web site, focusing promotional activity from March until the May ODAC on warnings and safety data, and hosting ongoing briefings with the oncology community."
Amgen's ongoing risk management activities includes working with the FDA to design additional pharmacovigilance studies to address safety concerns around ESAs, developing a patient medication guide to communicate the benefit/risk of ESAs, and continuing to publicly communicate updates on ESAs to the public and oncology community.
Important Aranesp and EPOGEN Safety Information
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of greater than or equal to 12 g/dL.
-- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of less than 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
-- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
-- Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled hypertension.
Amgen discovers, develops, manufacturers 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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SOURCE: Amgen Inc.
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