Navigation Links
Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today
Date:10/18/2010

THOUSAND OAKS, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today's meeting of the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

"This advisory committee meeting is a valuable forum for the FDA, Amgen and the nephrology community to review the results from TREAT, which further inform use of ESAs in patients with chronic renal failure who are not on dialysis," said Reshma Kewalramani, M.D., FASN, executive director, Global Development at Amgen. "We look forward to sharing our analyses of TREAT and describing proposed label changes that will help guide nephrologists in focusing their use of ESA therapy on patients most likely to benefit."

TREAT, the largest study of ESA use in CRF patients to date, is a randomized, double-blind, placebo-controlled, Phase 3 study of patients with moderate kidney dysfunction who were not on dialysis, had moderate anemia and type-2 diabetes and were treated to a hemoglobin target of 13 g/dL, a higher level than recommended in the current approved ESA label. The study did not meet its endpoints of demonstrating a reduction in all-cause mortality, cardiovascular morbidity or end-stage renal disease and showed an increased risk of stroke in the Aranesp (darbepoetin alfa) arm, among other key findings.

The results from TREAT provide important information about the cardiovascular risks of treating CRF patients with ESAs to a hemoglobin target of 13 g/dL or greater. Cardiovascular risks have been reflected in the boxed warning of the FDA-approved ESA labels since 2007 and, in December 2009, Amgen further strengthened the
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Arthritis Foundation Announces Amgen and Wyeth to Be Presenting Sponsor of the 2008 Arthritis Walk (R)
2. Medarex to Receive Milestone Payment from Amgen
3. AMT Obtains License to Amgens GDNF Gene to Develop Treatment for Parkinsons Disease with AMTs Proprietary Gene Therapy Platform
4. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
5. CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients
6. Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
7. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
8. Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes
9. Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
10. Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
11. Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... 2014  Early symptoms of diabetic eye and ... new technology, coupled with yearly, comprehensive eye exams, ... detection of eye diseases, including those associated with ... left untreated, these diseases can potentially lead to ... Recently, optometric researchers have deployed a new tool ...
(Date:10/22/2014)... WESTMINSTER, Colo. , Oct. 22, 2014   ... class of infusion systems designed to maximize targeted delivery ... is pleased to announce that oncologist John R. ... Norris Comprehensive Cancer Center, and surgical oncologist Steven ... Center have joined the Company,s Scientific Advisory Board (SAB).  ...
(Date:10/22/2014)... VIEW, Calif. , Oct. 22, 2014 ... a.m. EDTLOCATION: Online, complimentary registration available at: ... Team Leader Archana Vidyasekar and Visionary Innovation ... computers, WiFi-like wireless electricity, self-assembling materials, nanobots ... ten technologies which will transform our lives ...
Breaking Medicine Technology:Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 2Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 3Surefire Medical's Scientific Advisory Board Expands, Broadens Clinical Trial Expertise 2Futuristic Technologies That Will Transform Our World Beyond 2030 2Futuristic Technologies That Will Transform Our World Beyond 2030 3Futuristic Technologies That Will Transform Our World Beyond 2030 4
... committed to improving the health of its patients, workforce ... medical equipment to more eco-friendly alternatives that are free ... plastics that have been shown to harm human and ... purchase IV solution bags that are 100 percent PVC ...
... SHENZHEN, China, Jan. 19, 2012 /PRNewswire-Asia-FirstCall/ -- Mindray Medical ... developer, manufacturer and marketer of medical devices worldwide, today ... 2012 to be held between January 23 and 26 ... Health is the most important annual medical exhibition in ...
Cached Medicine Technology:Kaiser Permanente Moves to Green Medical Supplies by Converting to Eco-Friendly IV Equipment 2Kaiser Permanente Moves to Green Medical Supplies by Converting to Eco-Friendly IV Equipment 3Mindray Medical to Exhibit at Arab Health 2012 in Dubai from January 23-26 2
(Date:10/22/2014)... October 22, 2014 The ... which is dedicated to distribute health information technology ... delivery worldwide announced the development of six key ... expect when receiving healthcare. These are an expansion ... care: “providing care that is respectful of and ...
(Date:10/22/2014)... Best Cheap Hosting USA is among the most ... recently announced that iPower ( http://www.best-cheap-hosting-usa.com/go/iPower/ ) is the ... the world. , “iPower is one of the most ... various kinds of useful products for new and old ... customer service and a number of features which will ...
(Date:10/22/2014)... CA (PRWEB) October 22, 2014 Lintelus, ... Cormier, Sr. Vice President of Sales, will be speaking ... upcoming Meetings Technology Expo on October 28, at the ... be hosting a booth as well as a Tech ... Lintelus Meeting can create a more engaging event experience. ...
(Date:10/22/2014)... Salamon HealthDay Reporter , TUESDAY, ... vitro fertilization (IVF) are only about half as likely as ... technique, new research indicates, and the racial disparity persists even ... 31 percent of white patients became pregnant after IVF, compared ... than 4,000 IVF cycles over two years to tease out ...
(Date:10/22/2014)... 2014 (HealthDay News) -- Measures taken by Firestone officials ... Liberia may have limited the spread of the disease ... The Firestone Natural Rubber Co. provides health services to ... nearby densely populated communities. Between Aug. 1 and ... cases among those 80,000 people. That incidence rate of ...
Breaking Medicine News(10 mins):Health News:The Sullivan Institute for Healthcare Innovation Announces Release of Guiding Principles for Patient Experience-Centered Care 2Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 3Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2
... and EAST WINDSOR, N.J., Nov. 1, Warner Chilcott ... WCRX]) and NexMed, Inc. (Nasdaq: NEXM ),announced ... a licensing,agreement granting Warner Chilcott the exclusive U.S. ... treatment of erectile,dysfunction (ED). NexMed submitted a New ...
... help humans, team says , THURSDAY, Nov. 1 (HealthDay News) ... canine coat color, and the discovery could have implications for ... of Medicine says the finding may help lead to a ... have varying abilities to cope with stress. , They analyzed ...
... Assistant Professor of Surgery, Section of Vascular Surgery, at ... of Medicine, is the lead author of a research ... carotid artery occlusive disease should have carotid surgery or ... of the aortic arch that could help explain why ...
... They,re more likely to skip care because of costs ... 1 (HealthDay News) -- Although the United States spends ... other western countries, many Americans say they are forced ... errors, and say the health-care system needs to be ...
... Million ... Americans, ... VNUS ), a worldwide leader in medical devices,for the minimally invasive ... market growth of the VNUS,ClosureRFS(TM) Stylet, an endovenous radiofrequency (RF) ablation ...
... the Handicapped Association (NARHA) awards,Ashaway,s horse-assisted rehabilitative therapy with Premier ... ... Accreditation, ASHAWAY, R.I., Nov. 1 Turning Pointe,Therapeutic Riding ... North American Riding for the Handicapped Association (NARHA),the national standard ...
Cached Medicine News:Health News:Warner Chilcott and NexMed Sign U.S. Collaboration for Topical Alprostadil Treatment for Erectile Dysfunction 2Health News:Warner Chilcott and NexMed Sign U.S. Collaboration for Topical Alprostadil Treatment for Erectile Dysfunction 3Health News:Warner Chilcott and NexMed Sign U.S. Collaboration for Topical Alprostadil Treatment for Erectile Dysfunction 4Health News:Scientists Spot Dog Fur Color Gene 2Health News:Research sheds light on carotid artery stenting risk in elderly 2Health News:Research sheds light on carotid artery stenting risk in elderly 3Health News:Many Americans Dissatisfied With Their Medical Care 2Health News:Many Americans Dissatisfied With Their Medical Care 3Health News:Many Americans Dissatisfied With Their Medical Care 4Health News:Physicians Hail VNUS Device for Closing Diseased Perforating Veins 2Health News:Physicians Hail VNUS Device for Closing Diseased Perforating Veins 3Health News:Turning Pointe Therapeutic Riding Recognized for Excellence in Providing Equine-Assisted Therapies to People with Disabilities 2
Angulated, blunt tips....
Autoclavable reusable pencil for Aaron 800 & 1200 - comes with generator or 1/box....
... All Bovie LLETZ Loop ... wire for superior shape and ... They use a standard 3/32" ... loops are packaged in a ...
7 1/2" Handswitch Monopolar Forceps, Ins., Curved, Serrated...
Medicine Products: