Roche 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.

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.

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 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.