Roche announced that the European Commission has approved Mircera to treat anaemia associated with chronic kidney disease.
The Commission’s decision follows a Positive Opinion by the Committee for Medicinal Products for Human Use ( CHMP ) in May 2007, recommending granting marketing authorisation.

Mircera, a continuous erythropoietin receptor activator, has a different activity at the receptor level involved in stimulating red blood cell production which more closely mimics the body’s physiologic processes.

Mircera is the first ESA ( Erythropoiesis Stimulating Agent ) approved in the EU that offers a convenient dosing schedule of once every two weeks to correct anaemia in patients not previously treated. Mircera is also the first ESA to directly convert all patients previously treated with any ESA to once-monthly dosing. The safety and efficacy of Mircera in other indications has not been established.

The approval is based on efficacy and safety data from the largest clinical program ever carried out for a drug treating anaemia associated with CKD comprising 10 global studies involving more than 2,700 patients from 29 countries. Mircera is the only drug to have compared itself in its registration program to three ESAs: Epoetin alfa, Epoetin beta and Darbepoetin alfa.
Two correction and four maintenance trials were conducted in Phase III.

The safety data base from clinical trials comprised 2,737 CKD patients, including 1,789 patients treated with Mircera and 948 with another ESA. Approximately 6% of patients treated with Mircera are expected to experience adverse reactions. The most frequent reported adverse reaction was hypertension.

Globally more than 500 million people, approximately one in 10 of the general population, have some degree of chronic kidney disease. People with CKD experience a progressive deterioration in kidney function, often over a period of years until renal replacement therapy is needed. Patients whose kidneys are failing are unable to secrete erythropoietin, a protein that is produced by the kidneys and which stimulates the production of red blood cells in the bone marrow. Renal anaemia is a common and significant complication of CKD and is responsible for a significant proportion of the distressing and disabling symptoms that affect the daily health and quality of life of patients with CKD. Anaemia is also instrumental in the development of potentially fatal cardiovascular disease in patients with CKD; the prevalence of cardiovascular illness in all populations with kidney disease ( CKD not on dialysis, on dialysis and post-transplant ) is approximately 35-40 %.

Source: Roche, 2007

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