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Basel, 15 November 2007
FDA approves Mircera:
first renal anemia treatment in the US with monthly maintenance dosing
Roche
announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene
glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney disease (CKD) in patients
on dialysis and patients not on dialysis. Mircera is the only FDA-approved ESA to provide correction
of anemia with once-every-two-week dosing. Mircera is also the only FDA-approved ESA to maintain stable
hemoglobin levels with once-monthly or once-every-two-week dosing in all CKD patients. Mircera offers
the added convenience of storage at room temperature for extended time periods when necessary.
The
outcome of an ongoing patent case will determine when patients can gain access to Mircera in the United
States. Following approval by the European Agency for the Evaluation of Medicinal Products (EMEA), Mircera
has already been launched in Austria, Sweden, Germany, the UK and Norway and will continue its international
roll-out.
“The FDA approval for our innovative anaemia treatment Mircera
is another significant milestone for Roche, Mircera has now been reviewed and approved by both the FDA
and the EMEA, two of the world´s leading regulatory authorities”, said William M. Burns, CEO Roche Pharma.
In contrast to erythropoietin, Mircera is an erythropoietin receptor
activator with greater activity in vivo as well as increased half-life. Mircera has the longest half-life
of all FDA-approved erythropoiesis stimulating agents (ESAs)1,2,3, up to
six times longer than darbepoetin alfa and up to 20 times longer than epoetin.
The
Phase III data supporting the FDA approval for Mircera consisted of two correction and four maintenance
studies exploring intravenous (IV) and subcutaneous (SC) Mircera at extended administration intervals.2,3,4,5,9,10,11
The initial registration clinical program for Mircera consisted of 10 global studies involving more
than 2,700 patients from 29 countries6.
In clinical trials,
Mircera was as effective as commercially available agents in correcting renal anemia in patients with
CRF on dialysis and not on dialysis. Up to 97.5 percent of patients who were not currently receiving
an ESA achieved target Hb levels (>=11g/dL) with once-every two week dosing of Mircera7.
Patients maintained stable Hb levels (±1g/dL) when switched to once-monthly Mircera from a shorter-acting
frequently administered ESA treatment regimen8,9,10,11,12. Mircera has a
safety profile comparable to other erythropoietic agents.
In the European
Union (EU), Mircera is the first ESA approved to directly convert all CKD patient types previously treated
with any ESA to once-monthly maintenance dosing. It is also the first ESA in the EU that offers a convenient
dosing schedule of once every two weeks to correct anaemia in all CKD patient types not previously treated.
About Roche
Headquartered in Basel,
Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products
and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes
on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader
in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active
in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics
Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D
agreements and strategic alliances with numerous partners, including majority ownership interests in
Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
For
video content from Roche related to anaemia please log on to www.thenewsmarket.com/roche,
where you can order broadcast-standard video to be received digitally or by tape. Registration and video
is free to the media.
Additional information about renal anaemia is available
on the Internet at www.AnaemiaWorld.com
All
trademarks used or mentioned in this release are protected by law.
References
1)
Detail aide, p2: MIRCERA PI, p2/lines 45-48
2) ARANESP PI, p2/ ¶1
3) EPOGEN
PI, p3/ ¶4
4) Detail aide, p4: DOF/ISE Corr, p116/figure 12
5) Detail
aide, p4: DOF/CSR, p358, per data points 10.22-baseline 11.38 wk 6
6) Dutka, Paula, Dalton,
Cheryl, Beswick, Richard, Essig, Juliane, Vogel, Susan. Oral Presentation Abstract to be Presented at
ANNA. Safety and tolerability of C.E.R.A. (continuous erythropoietin receptor activator) in patients
with chronic kidney disease (CKD): pooled data from the phase II-III trials, 2007, Dallas, Texas.
7)
Detail aide, p4: MIRCERA PI, p3/lines 97-99
8) Locatelli F, Sulowicz W, Harris K, Selgas
R, Kaufman J, Klinger M, Malberti F, Dougherty F. Poster Presented at ASN. SC C.E.R.A. (Continuous Erythropoietin
Receptor Activator) Once Every 2 Weeks or Once Monthly Maintains Stable Hb Levels after Converting Directly
from SC Epoetin 1-3 Times per Week in Patients with CKD on Dialysis (PROTOS), 2006, San Diego, California.
9)
Fishbane S, Levin N, Mann J, Lewis J, Bernardo M, Lunde N, Dougherty F. Poster Presented at ASN. IV
C.E.R.A. (Continuous Erythropoietin Receptor Activator) Once Every 2 Weeks or Once Monthly Maintains
Stable Hb Levels after Converting Directly from IV Epoetin 1-3 Times per Week in Patients with CKD on
Dialysis (MAXIMA), 2006, San Diego, California.
10) Ryckelynck, Jean-Philippe, Harris,
Kevin, Selgas, Rafael, Stompor, Thomas, Ladányi, Erzsebet, Opatrna, Sylvie, Dougherty Frank C. Poster
Presented at ASN. SC C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered up to Once
Monthly in Patients with CKD on Dialysis Maintains Adequate Hb Levels Regardless of Age, Gender or Diabetic
Status (PROTOS), 2006, San Diego, California.
11) Levin, Nathan W., Imbasciati, Enrico,
Combe, Christian, Rocco, Michael V., Lok, Charmaine E., Donnelly, Sandra M., Dougherty, Frank C. Poster
Presented at ASN. Adequate Hb Levels are Maintained with IV C.E.R.A (Continuous Erythropoietin Receptor
Activator) Administered up to Once Monthly in Dialysis Patients Irrespective of Age, Gender or Diabetic
Status (MAXIMA), 2006, San Diego, California.
12) Detail aide, p5: DOF/ISE Main, pp67
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Roche's new medicine Mircera
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