Navigation Links
Data Analyses Outline Efficacy and Safety of Mircera for the,Treatment of Renal Anemia Associated With Chronic Kidney Disease

ORLANDO, Fla. and NUTLEY, N.J., April 12, 2007 /PRNewswire-FirstCall/ -- Data analyses from the largest initial registration clinical trial program ever undertaken in the renal anemia arena provide efficacy and safety information on the investigational anemia therapy MIRCERA(TM) for the treatment of renal anemia associated with chronic kidney disease (CKD) in patients on dialysis and not on dialysis. Three data analyses were presented at the National Kidney Foundation 2007 Spring Clinical Meetings in Orlando, Florida.

According to these analyses, MIRCERA with extended dosing up to once every four weeks: (1) corrected and maintained hemoglobin (Hb) levels in patients with CKD, on dialysis and not on dialysis; (2) maintained Hb levels in dialysis patients, regardless of congestive heart failure (CHF) status as shown in a post-hoc analysis; and (3) exhibited a safety profile that is consistent with that of commercially available erythropoiesis stimulating agents (ESAs) and typical of those associated with this patient population.

"The goal in treating renal anemia is to safely maintain target hemoglobin levels," said Steven Fishbane, MD, Associate Director of Nephrology, Associate Chairman of the Department of Medicine, and Director of End-Stage Renal Disease research at Winthrop University Hospital. "These data analyses clearly demonstrate that MIRCERA corrected low hemoglobin levels, and maintained target hemoglobin levels with the added convenience of up to once- monthly dosing."

About the Studies

Safety and Tolerability of C.E.R.A. In Patients With Chronic Kidney Disease: Pooled Data From Ten Phase II-III Trials

Pooled data from four Phase II and six Phase III studies evaluated the safety and tolerability of MIRCERA (intravenous (IV) and subcutaneous (SC)) in patients not previously treated with commercially available ESAs and those previously treated with commercially availa ble ESAs. This data analysis showed that the incidence of adverse events in the Phase II and III safety population was similar between MIRCERA and reference groups, and typical of those associated with this patient population; and the administration of MIRCERA for the treatment of anemia associated with CKD has a safety profile consistent with that of reference ESAs.

C.E.R.A. Once Monthly Maintains Stable Hemoglobin Levels In Patients With Chronic Kidney Disease on Dialysis With and Without Congestive Heart Failure (CHF)

This retrospective analysis of two Phase III studies evaluated the efficacy and tolerability of MIRCERA (IV and SC) administered once every two weeks or once every four weeks in patients with or without congestive heart failure who were on dialysis and were directly converted from epoetin alfa or

beta. The post-hoc analysis showed that MIRCERA, administered at extended dosing intervals, was effective in maintaining stable Hb levels in dialysis patients with and without CHF who were directly switched from shorter-acting ESAs.

Efficacy of C.E.R.A. in Treatment of Renal Anemia: Overview of 6 Global Phase III Trials

This was an overview of six global studies in approximately 2,400 patients that compared MIRCERA with epoetin alfa or beta and with darbepoetin alfa. This overview showed that the efficacy of MIRCERA was comparable to that of the comparator agents, but required less frequent administration.

Chronic Kidney Disease and Renal Anemia

According to the National Kidney Foundation, 20 million Americans have chronic kidney disease and another 20 million are at increased risk for the condition. CKD is considered a rising global epidemic because it is linked to two of the fastest-growing diseases - diabetes and hypertension. An often under-diagnosed condition, CKD is called a disease multiplier because many of its risk factors are also complications of the disease itself, creating a relentless spiral in which one condition can lead to the exacerbation of the other and, ultimately, to death. In particular, renal anemia, diabetes and cardiovascular disease frequently play this double role.

About MIRCERA

The initial registration clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III program for MIRCERA consisted of two correction and four maintenance studies exploring intravenous and subcutaneous MIRCERA at extended administration intervals.

Roche filed applications with the regulatory authorities in the United States and in the European Union in April 2006 seeking approval for the use in the treatment of anemia associated with CKD in patients on dialysis and not on dialysis.

Safety Information

MIRCERA has a demonstrated safety profile comparable to other erythropoietic agents.

The most commonly reported adverse events in the MIRCERA Phase II/III clinical program were hypertension, nasopharyngitis and diarrhea. Erythropoietic therapies increase the risk of death and serious cardiovascular events when administered to a hemoglobin of greater than 12 g/dL.

Erythropoiesis stimulating agents, when administered to target a hemoglobin of greater than 12 g/dL have shortened the time to tumor progression, shortened survival and increased the risk of death in cancer patients.

Pure Red Cell Aplasia (PRCA) has been observed in patients treated with erythropoietin therapy. However, PRCA has not been observed with MIRCERA in clinical trials to date.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treat ment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top -Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in

America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.

All trademarks used or mentioned in this release are protected by law.

CONTACT: Linda Dyson, of Roche, +1-973-562-2231, ;David Freundel, of Manning Selvage & Lee for Roche, +1-212-468-3982,Mobile: +1-917-806-6625, linda.dyson@roche.com david.freundel@mslpr.com

Web site: http://www.rocheusa.com/http://www.roche.us/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. New Study Analyses Confirm Once-Daily Seroquel XR Extended-Release Tablets as Effective Treatment for Schizophrenia
2. New Long-Term Data Analyses for Bifeprunox Show Favorable Effects Versus Placebo in Stabilized Patients with Schizophrenia
3. Medivation Announces Presentation of New Subset Analyses From Dimebon Phase 2 Alzheimers Disease Trial at American Academy of Neurology Annual Meeting
4. Safety Analyses of Clinical Data for Bifeprunox in Patients with Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar to Placebo
5. Lipitor Significantly Lowered Hospitalization Costs for Patients with Heart Disease, Two New Analyses Show
6. Prospective Model Outlined Potential Time and Cost Savings of Once-Monthly Anemia Treatment
7. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
10. Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial
11. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , Dec. 2, 2016  LifeVac, the revolutionary ... included in the Emergency Response Training and Support Services ... excited to have LifeVac become part of the ERTSS ... Founder and CEO of LifeVac. "Having an established network ... and effectively will help leverage our efforts to spread ...
(Date:12/2/2016)... -- PipelineRx, a leading medication management technology company focused ... its SaaS-based telepharmacy platform, PowerGridRx™ , at ... Clinical Meeting and Exhibition, December 5-7 in ... hospital clients nationally, the Company is a leader ... improve pharmacy operations, enhance patient safety, and reduce ...
(Date:12/2/2016)... 2, 2016  Maxor National Pharmacy Services, LLC ("Maxor"), today ... Inc. ("PSI").  The combination of Texas -based ... -based PSI bring together both company,s clinical expertise and high-touch ... an industry-leading specialty pharmacy. About Maxor ... , , ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... ... years, Doctors on Liens has published a directory of the top doctors working ... When the company started in 1997, the directory was a single page focusing on chiropractors ... directory features a vast array of medical specialists stretching from Sacramento to San ...
(Date:12/2/2016)... ... December 02, 2016 , ... Center for Autism and ... of those affected by autism spectrum disorder (ASD) and other developmental disabilities. The group, ... will give parents and other caregivers the opportunity to share stories and advice, seek ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet’s newest campaign, ... standing as living proof that attitude and determination can combine into the most ... spike around the holidays. This campaign will offer patients a new-found hope, by ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... version of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite helps biobanks, clinical, research ... labeling, storing, shipping and disposal. The new version is a faster and a ...
(Date:12/2/2016)... Wexford, PA (PRWEB) , ... December 02, 2016 , ... ... manages stress and overall health, day and night. No other wearable health technology on ... management. We wanted to give poeple more meaningful insights about their health than ...
Breaking Medicine News(10 mins):