BASEL, Switzerland, April 27 /PRNewswire/ --
-- New Monthly Therapy Advances Renal Anaemia Management Beyond Capabilities of Existing Drugs(i)
Roche, a world leader in biotechnology, today announced it has submitted a marketing authorization application to the European Medicines Agency for its novel treatment of anaemia associated with chronic kidney disease (CKD). The application, which follows the filing in the United States on 19 April, includes both patients on dialysis and not on dialysis.
Roche's innovative investigational anti-anaemia agent is the first CERA, a Continuous Erythropoietin Receptor Activator, which is a new class of drugs. Its activity at receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs. The distinct molecular interaction of this CERA is believed to play an important role in providing targeted, stable and sustained control of anaemia. This CERA is the only anti-anaemia treatment to have been studied with long dosing intervals of up to once monthly for its initial filing.
"At the outset we made a strategic decision at Roche to study longer dosing intervals with our CERA recognizing that the needs of physicians and patients were changing," said Eduard Holdener, Global Head Pharmaceutical Development, Roche. "With the long half-life that it naturally has, we can achieve a more predictable and sustained control of patient's haemoglobin as well as potentially offering treatment efficiencies with less frequent dosing."
With approximately one person in 10 in the general population having some degree of CKD(1), it is considered a rising global epidemic and is linked to two of the fastest-growing diseases -- diabetes and cardiovascular disease. Renal anaemia is a common complication of CKD that impacts morbidity, mortality and quality of life. Maintaining haemoglobin (Hb) levels -- a key indicator of anaemia -- within guideline ranges is central to managing this condition. Renal anaemia remains a major challenge as nearly 60 percent of people on dialysis who are currently being treated for it have Hb levels that aren't within accepted ranges.(2)
The largest and most comprehensive Phase III program ever was launched in 2004 with the objective of establishing the efficacy and safety profile of this CERA in CKD patients. In total, six different studies focusing on treatment (correction) of anaemia and maintenance (conversion from an existing therapy) were conducted in 29 countries across the globe involving more than 2,400 patients.
Using state-of-the-art protocol design and rigorous statistical testing, these six studies provided an opportunity to evaluate the efficacy and safety of CERA at extended intervals (once every two weeks in correction and up to once every four weeks in maintenance) in CKD patients on dialysis and not on dialysis and also in erythropoietin-stimulating agent (ESA)-naive patients and previously treated patients using all approved and available ESAs as comparators. All six Phase III trials were successfully completed and met their primary endpoints.
About Renal Anaemia
Anaemia is a condition characterized by a lower than normal level of red blood cells or the haemoglobin in them. Haemoglobin enables red blood cells to carry oxygen throughout the body. When the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness, pale skin and other symptoms. Other serious clinical complications will appear as the body -- in particular, the heart -- works harder to compensate for the lack of oxygen.
Normally, when the body senses a decrease in available oxygen, more erythropoietin (a protein produced by the kidneys) is created. This protein stimulates the production of oxygen-carrying red blood cells in the bone marrow which raises the red blood cell count. When this natural mechanism is hindered (as in patients with kidney disease), it is necessary to stimulate the receptors to produce red blood cells which is what CERA is designed to do. The goal of treatment is to increase haemoglobin back to a desirable level and maintain that level over time.
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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries 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 (http://www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Roche Group Media Office
Phone: +41-61-688-8888 / e-mail: basel.mediaoffice@roche.com
- Baschi Durr
- Alexander Klauser
- Daniel Piller (Head of Roche Group Media Office)
- Katja Prowald (Head of R&D Communications)
- Martina Rupp
Note to Editor:
(i) ESAs (Erythropoietin Stimulating Agents) is the term given for drugs that stimulate the production of red blood cells. The first ESAs on the market were recombinant human erythropoietins (referred to as rhEPOs or EPOs or epoetins) which were approved in the late 1980s or early 1990s. These short-acting drugs are generally administered three times a week to correct anaemia. There is no drug commercially available that is a pegylated epoetin. These were followed by a Novel Erythropoietin Stimulating Protein (NESP) of which there is darbepoetin alfa. This drug is given once weekly or once every two weeks to correct anaemia. The new Roche compound is the first of a new class called continuous erythropoietin receptor activator (a CERA). CERA is an acronym that describes a substance class and is not the brand name. This drug examined the correction of anaemia with a once every two-week dose interval and a once monthly dose interval for maintenance of haemoglobin in chronic kidney disease patients.
(1) International Federation of Kidney Foundations fact sheet; World
Kidney Day 2006.www.ifkf.net.
(2) Lascon E et al: Effect of Variability in Anemia Management on
Hemoglobin Outcomes in ESRD. Am J Kidney Dis:41:111-124, 2003.
Web site: http://www.roche.com
Roche Group Media Office: +41-61-688-8888, or basel.mediaoffice@roche.com
