Amgen - In the News - ESAs in the News

In the News

ESAs in the News


Sep. 01, 2011	Amgen Statement on Proposed Changes to the Quality Incentive Program in Dialysis
Jun. 24, 2011	Amgen Posts Modified ESA Labeling
Jan. 19, 2011	Amgen Presents at MEDCAC Meeting on ESAs in Chronic Kidney Disease
Oct. 18, 2010	Amgen's Statement Following FDA CRDAC Meeting
Oct. 18, 2010	Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today
Oct. 14, 2010	Amgen Statement on Posting of Briefing Documents for the Review of TREAT Results at the FDA's CRDAC Meeting
Sep. 24, 2010	Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa)
Sep. 21, 2010	FDA to Review Use of ESAs in Chronic Renal Failure at Cardiovascular and Renal Drugs Advisory Committee
Jul. 26, 2010	Amgen's Statement on the Dialysis Facility Bundle
Jul. 16, 2010	Amgen's Comments on the CMS NCA for ESAs in Chronic Kidney Disease
Mar. 24, 2010	Amgen Presents at MEDCAC Meeting on ESAs in Chronic Kidney Disease
Feb. 16, 2010	Amgen Finalizes ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA
Dec. 16, 2009	Amgen Issues Statement on Update to U.S. Prescribing Information for Erythropoiesis-Stimulating Agents (ESAs)
Dec. 16, 2009	Letter to Healthcare Professionals
Nov. 16, 2009	Amgen Statement on TREAT Results Presented at the American Heart Association Scientific Sessions 2009
Oct. 30, 2009	Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints
Aug. 25, 2009	Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events with Aranesp® Therapy (TREAT) In CKD Patients with Type 2 Diabetes
Apr. 09, 2009	Amgen Issues Statement on Prescribing Information Update for Erythropoiesis-Stimulating Agents (ESAs)
Apr. 09, 2009	Letter to Healthcare Professionals
Nov. 06, 2008	EU Commission Approves Updated Prescribing Information for ESAs
Oct. 02, 2008	District Court Affirms Patent Infringement Rulings and Finds That Amgen is Entitled to a Permanent Injunction against Roche
Sept. 30, 2008	Amgen Receives Executive Summary from Independent Cochrane Collaboration Review of ESAs in Oncology
Sept. 26, 2008	FDA Posts Early Communication about the Use of Epoetin Alfa for Potential Neuroprotective Effects
Aug. 7, 2008	Amgen Posts Updated ESA Labeling
Jul. 30, 2008	Amgen Issues Statement in Response to Revised ESA Labeling from the FDA
May 8, 2008	Amgen Statement on Aranesp '145 Manuscript' In the Journal of Clinical Oncology
May 6, 2008	Amgen Statement on U.S. Food and Drug Administration approval of Aranesp® Q2W dosing for de novo correction of anemia in patients with chronic renal failure (CRF)
Mar. 13, 2008	Amgen Discusses Benefits and Risks of ESA Treatment for Cancer Patients with Anemia Due to Chemotherapy at FDA ODAC Meeting
Mar. 11, 2008	Amgen Statement on Briefing Materials Prepared for March 13, 2008 ODAC Meeting
Mar. 7, 2008	Letter to Healthcare Professionals
Mar. 7, 2008	Amgen Announces Update to U.S. Prescribing Information for Aranesp® and EPOGEN®
Dec. 4, 2007	Amgen statement on the Gynecologic Oncology Group study on Epoetin Alfa
Nov. 13, 2007	Amgen New Evidence Reconsideration Request
Nov. 8 , 2007	Amgen to Provide New Evidence as Part of a Formal Reconsideration of CMS' National Coverage Determination on ESAs
Oct. 23, 2007	Amgen's Ongoing Commitment to the Safety of its ESA Products: New Pharmacovigilance Program Proposed
Oct. 23, 2007	Jury Rules Roche Infringes Amgen's EPO Patents
Sept. 11, 2007	Press Release: Amgen to Review Benefits, Risks of ESA Therapy in Chronic Renal Failure Patients at FDA Advisory Committee
Sept. 7, 2007	Amgen to Present at FDA CRDAC Meeting Sept. 11
July 31, 2007	Press Release: Amgen Responds to Final CMS National Coverage Determination on Use of Erythropoiesis-Stimulating Agents in Oncology
June 26, 2007	Press Release: Amgen Submits Testimony to House Ways & Means Committee
June 26, 2007	Summary of Amgen Testimony to House Ways & Means Committee
June 26, 2007	Amgen Submission to House Ways & Means Committeee
June 19, 2007	Amgen's Further Response to Senator Charles Grassley Regarding ESA Safety
June 12, 2007	Amgen's Response to Senator Charles Grassley Regarding ESA Safety
June 2, 2007	Amgen's Response to CMS Proposed Decision Memorandum for ESAs for Non-Renal Disease Indications
May 31, 2007	Amgen's Policy on Sharing Our Clinical Trial Results
May 31, 2007	Amgen's Position on Ethical Marketing of ESAs
May 21, 2007	Amgen CEO Kevin Sharer's Letter to the Editor of the New York Times Regarding the Use of ESAs

Background Documents

Prescribing information for Aranesp®

Prescribing information for EPOGEN®

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