Data Analyses Outline Efficacy And Safety Of MIRCERA(TM) For The Treatment Of Renal Anemia Associated With Chronic Kidney Disease

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

“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 available 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

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


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

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

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 treatment 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: rocheusa or

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