Amgen Responds to Reports About Use and Safety of EPOGEN and Aranesp in CKD Anemia Therapy.THOUSAND OAKS, Calif. -- Amgen (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMGN), today posted to its corporate web site documents intended to clarify Amgen's position on the use of EPOGEN([R]) (Epoetin alfa e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: ) and Aranesp([R]) (darbepoetin alfa darbepoetin alfa Aranesp Pharmacologic class: Recombinant human erythropoietin Therapeutic class: Hematopoietic Pregnancy risk category C FDA Boxed Warning) and to correct what the company believes are misleading and inaccurate news reports regarding the use of its drugs. Amgen's mission is to serve patients and the company is committed to ensuring the highest standards of patient safety.Documents supporting the following statements have been posted on the company's web site (www.amgen.com) under the link Amgen Responds to Reports About the Use and Safety of its Products. The documents include: 1) Amgen's Response to Reports about the Use and Safety of its Products in Anemia Therapy; 2) Amgen's Response to the CHOIR and CREATE Clinical Trial Data; 3) Amgen's Letter to Nephrologists and 4) an interview with the Center for Medicare & Medicaid Services (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) Chief Medical Officer Barry Straube that was initially published in Inside CMS. * EPOGEN and Aranesp are effective and safe medicines when administered according to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) label. * Amgen only promotes the use of EPOGEN and Aranesp consistent with the FDA label. * Hemoglobin maintenance is difficult and physicians are not necessarily acting inappropriately when patients' hemoglobin levels temporarily exceed the FDA label target range. * CMS reimbursement guidelines are consistent with the FDA labeling policy and allow doctors to provide patients with the best possible care. * Changes to current guidelines should be approached judiciously and based on the rigorous review of data and patient care. The company will also submit written testimony to the House Ways & Means Committee, which is scheduled to hold a hearing Wednesday, Dec. 6, on safety and quality for Medicare beneficiaries with End Stage Renal Disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg . That testimony will be posted to the company's web site under this link upon submission to the committee. About Amgen Amgen discovers, develops 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, 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 Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , 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. |
|
|||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion