BASEL, Switzerland, May 25 /PRNewswire/ -- Roche announced today that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorisation be granted for MIRCERA for the treatment of anaemia associated with chronic kidney disease. MIRCERA is a new long-acting chemically synthesized erythropoiesis-stimulating agent (ESA).
The positive opinion recommends the following use of MIRCERA in the treatment of anaemia associated with chronic kidney disease:
-- once every two weeks as a single intravenous or subcutaneous injection to increase haemoglobin levels (the oxygen-transporting protein housed in red blood cells) for the initial correction of anaemia in patients not currently treated with an ESA;
-- once monthly as a single intravenous or subcutaneous injection to maintain target haemoglobin levels for patients currently being treated with an ESA (epoetin alfa, epoetin beta and darbepoetin alfa) who are converted to treatment with MIRCERA.
The safety and efficacy of MIRCERA therapy in other indications has not been established.
When approved by the European Commission, MIRCERA will become the first and only ESA to have such a dosing schedule in the EU. This represents a significant step forward in improving patient management.
MIRCERA has been designed to overcome the shortcomings of currently used ESAs. It has been shown to provide stable maintenance of haemoglobin with only 12 injections a year (i),(ii), (iii),(iv),(v) which may allow overworked renal units to devote more time to other patient needs.
"As one of the largest biotechnology companies in the world, it is Roche's ambition to create clinically differentiated medicines that meet unmet medical needs and this positive opinion for MIRCERA marks another milestone in this effort," said William M. Burns, CEO of the Pharma Division at Roche. "We have been the leader in anaemia management for many years now and we look forward to providing this newest innovation to physicians and patients in Europe in the near future."
The positive opinion is based on a submission which included data from the largest Phase II-III program ever carried out for a drug treating anaemia associated with chronic kidney disease comprising 10 global studies involving more than 2,700 patients from 29 countries. The phase III program consisted of six pivotal studies that explored the use of MIRCERA to correct anaemia in untreated patients and to maintain haemoglobin after conversion from treatment regimens using existing agents. This program consisted of two correction and four maintenance studies of both intravenous and subcutaneous MIRCERA given at longer dosing intervals of up to once every four weeks.
About MIRCERA
MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin. MIRCERA is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa.
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.
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Notes to the Editor:
The Phase III study program consisted of two correction and four maintenance studies. Correction is a term that is used to describe the initial phase of treatment for patients with chronic kidney disease (CKD) who have been diagnosed with anaemia but who are not currently receiving treatment with an agent to increase their Hb level. Maintenance refers to keeping Hb levels in a defined range over time in patients whose Hb levels have been corrected and are currently treated with an agent.
In correction, the primary endpoint was the haemoglobin (Hb) response rate during the correction period. The criteria for response was Hb increase>1 g/dL above baseline and Hb >11 g/dL during correction period without RBC transfusion.
-- The first study (AMICUS) was designed to evaluate anaemia correction with IV MIRCERA once every 2 weeks in naïve patients with CKD on dialysis vs. epoetin.
-- The second study (ARCTOS) was designed to evaluate anaemia correction with SC MIRCERA once every 2 weeks in naïve patients with CKD not on dialysis vs. darbepoetin alfa
In maintenance, the primary endpoint was the change in Hb concentration between baseline and the evaluation period:
-- The first study (MAXIMA) was designed to evaluate IV CERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on IV epoetin. IV epoetin was dosed up to three times weekly compared to CERA dosed once every two weeks or once every four weeks.
-- The second study (PROTOS) was designed to evaluate SC MIRCERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on SC epoetin. SC epoetin was administered up to three times weekly, compared to CERA dosed either once every two weeks or once every four weeks.
-- The third study (STRIATA) was designed to evaluate IV MIRCERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on IV darbepoetin alfa. Darbepoetin alfa was dosed once a week or once every two weeks compared to CERA dosed once every two weeks.
-- The fourth study (RUBRA) was designed to evaluate SC or IV MIRCERA in a pre-filled syringe in the maintenance of Hb levels in patients on dialysis previously maintained on epoetin. Epoetin was administered up to three times weekly compared to CERA administered once every two weeks.
(i) Levin N et al. Poster SO23, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
(ii) Sulowicz W et al. Poster: SP424, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
(iii) Canaud B et al. Poster: SP425, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
(iv) Macdougall I et al. Poster SAPO208, 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006.
(v) Klinger M et al. Poster SAPO212, 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006.
For further information please contact: Sheila Gies, Roche, Tel: +1-973-235-4347, Mobile: +1-973-687-0188, Rosemary Hennings, Galliard Healthcare, Tel: +44-(0)20-7663-2253, Mobile: +44-(0)7799-411325
