Roche’s New Long-acting ESA* For The Treatment Of Renal Anaemia Receives Positive Opinion In Europe

Roche announced today that methoxy polyethylene glycol-epoetin beta (MIRCERA®), a new long-acting erythropoietin stimulating agent (ESA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The positive opinion recommends its use in the treatment of anaemia associated with chronic kidney disease:

— once every two weeks to increase haemoglobin (Hb) levels for the initial correction of anaemia in patients not currently treated with an ESA;

— once monthly to maintain target Hb levels for patients currently being treated with an ESA (epoetin alfa, epoetin beta and darbepoetin alfa) who are converted to this treatment

Roche’s new once-monthly ESA has been shown to effectively stabilise Hb levels1,2 and on approval will become the first and only once-monthly treatment for all adult CKD patients with renal anaemia.

Dr Richard Fluck from Derby City General Hospital commented, “I welcome this news from the CHMP. This new option in anaemia management may help to reduce the time both healthcare professionals and patients spend dealing with this debilitating complication of renal disease. The ability to offer patients a choice of treatments is essential in providing a patient-centered approach to care and improving long-term patient outcomes.”

The CHMP positive opinion is based on results from the largest phase III programme ever carried out for a CKD-induced anaemia treatment. Over 2,700 patients from 29 countries, including the UK, participated in 10 global studies for the programme. Six pivotal studies explored the use of Roche’s long-acting ESA to correct anaemia in untreated patients and to maintain haemoglobin after conversion from treatment regimens using existing agents. The programme featured two correction and four maintenance studies with both intravenous (iv) and subcutaneous (sc) methoxy polyethylene glycol-epoetin beta given at longer dosing intervals of up to once every four weeks.1-6

William M. Burns, CEO of the Pharma Division at Roche said, “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 marks another milestone in this effort. 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”.

[1][*] Erythropoietin stimulating agent

Roche’s new ESA (methoxy polyethylene glycol-epoetin beta):

— Is a long-acting ESA designed to mimic the action of erythropoietin, a hormone produced by the kidneys to stimulate red blood cell production, in order to make up for a shortage of the natural hormone in patients with renal anaemia

— Differs from existing ESAs by its mechanism of action7-8,long half-life9, and by being the first anti-anaemia agent which was specifically designed to provide long dosing intervals of up to once a month

About CHMP positive opinion:

The positive opinion recommends the following use of Roche’s long-acting ESA in the treatment of CKD-induced anaemia:

— Once every two weeks to increase haemoglobin (Hb) 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 to maintain target Hb levels for patients currently being treated with an ESA (epoetin alfa, epoetin beta and darbepoetin alfa) who are converted to treatment with Roche’s long-acting ESA

About the Phase III study programme:

The phase III study programme 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 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 red blood cell (RBC) transfusion.

— The first study (AMICUS) was designed to evaluate anaemia correction with Roche’s long-acting ESA (iv) once every 2 weeks in naïve patients with CKD on dialysis vs. epoetin.4

— The second study (ARCTOS) was designed to evaluate anaemia correction with Roche’s long-acting ESA (sc) once every 2 weeks in naïve patients with CKD not on dialysis vs. darbepoetin alfa.5

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 Roche’s long-acting ESA (iv) in the maintenance of Hb levels in CKD patients on dialysis previously maintained on iv epoetin. Intravenous epoetin was dosed up to three times weekly compared to Roche’s long-acting ESA dosed once every two weeks or once every four weeks.1

— The second study (PROTOS) was designed to evaluate Roche’s long-acting ESA (sc) in the maintenance of Hb levels in CKD patients on dialysis previously maintained on sc epoetin. Subcutaneous epoetin was administered up to three times weekly, compared to Roche’s long-acting ESA dosed either once every two weeks or once every four weeks.2

— The third study (STRIATA) was designed to evaluate Roche’s long-acting ESA (iv) 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 Roche’s long-acting ESA dosed once every two weeks.3

— The fourth study (RUBRA) was designed to evaluate Roche’s long-acting ESA (sc or iv) 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 Roche’s long-acting ESA administered once every two weeks.6

About CKD and renal anaemia

— Chronic kidney disease (CKD) leads to permanent loss of kidney function and results from damage to the kidney tissue.

— Approximately one in ten people have CKD. 10 In patients aged over 75 years, CKD is present in one out of two people.11 Renal failure kills more than 7,000 people in the UK every year.12

— Anaemia is a common complication of CKD and there are approximately 100,000 people in the UK with CKD who also have anaemia.13

Roche in anaemia

— Roche has been committed to improving the lives of patients with anaemia for over 15 years through the provision of treatment and the support of innovative programmes, such as the Roche Foundation for Anaemia Research (RoFAR). By founding RoFAR, Roche aims to encourage new research that will take knowledge and understanding of anaemia and the use of anti-anaemia agents into new areas of medicine, such as neurology and cardiology.

— Roche’s contribution to the management of anaemia in both renal disease and cancer has been pioneered through the availability of NeoRecormon® (epoetin beta), which has been prescribed widely since it was first approved for use in 1991.

References

1. Levin N et al. Poster SO23, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
2. Sulowicz W et al. Poster: SP424, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
3. Canaud B et al. Poster: SP425, 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
4. Klinger M et al. Poster SAPO212, Poster SAPO208, 39th annual meeting of the American Society of Nephrology ,San Diego, USA, 2006
5. Macdougall I et al. Poster SAPO208, 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006.
6. Spinowitz B et al. Abstract 376. 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006.
7. Macdougall I et al. Annual meeting of the American Society of Nephrology, San Diego, USA, 2003
8. Brandt M et al. 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006.
9. Madcougall I et al. SAP0926. 38th Annual meeting of the American Society of Nephrology, St. Louis, USA, 2005.
10. International Federation of Kidney Foundations. World Kidney Day facts; 2007 (accessed April 2007)
11. The National Kidney Federation website. Available at kidney [accessed April 2007]
12. National Kidney Federation transplant facts. Available at kidney/living-donor/factsht.html [accessed April 2007]
13. National Collaborating Centre for Chronic Conditions at the Royal College of Physicians. Anaemia management in chronic kidney disease: national clinical guidelines for management in adults and children. March 2006-7

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