Roche announced that the European Commission has approved its innovative drug Mircera to treat anaemia associated with chronic kidney disease (CKD). The approval of Mircera results in a single marketing authorisation with unified labelling for EU countries, which is valid in all 27 EU member states.
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. This is believed to be instrumental in delivering predictable and stable haemoglobin levels with once-monthly dosing.
"We have been a leader in anaemia management for nearly 20 years and the approval of Mircera is a testament to the dedication of our scientists to create a novel compound, as well as to the physicians around the world who have participated in the largest clinical trial program ever for a drug treating renal anaemia," said William M Burns, CEO of the Pharma Division at Roche. "Mircera has the potential to deliver real clinical benefits in the management of renal anaemia and provide the right frequency of treatment for all CKD patients."
Mircera is the first ESA 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.
Once-monthly Mircera may enable health care professionals to spend more time on other aspects of CKD patient care. In fact, data from a study recently presented found that converting dialysis patients from more frequently administered ESAs to once-monthly Mircera, could cut nearly in half the annual time spent on anaemia management in a dialysis centre.
Today's 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, beta and darbepoetin alfa. Two correction and four maintenance trials were conducted in Phase III. The aim of anaemia management is to safely and smoothly increase low haemoglobin (Hb) levels to a desired target range and then to maintain patients in this range to avoid health complications.
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 per cent of patients treated with Mircera are expected to experience adverse reactions. The most frequent reported adverse reaction was hypertension.