Roche gets positive CHMP opinion on kidney disease drug

Roche has announced that Mircera has been awarded a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) as a treatment for anaemia related to chronic kidney disease.

Mircera is a continuous chemically synthesised erythropoiesis-stimulating agent (ESA) that has an increased half-life compared to erythropoietin, in addition to increased in vivo activity and reduced in vitro specific activity.

It has been designed to facilitate the constant maintenance of haemoglobin in patients with 12 injections per year – fewer than that for existing ESAs – in order to free time in renal units.

The CHMP recommends that in patients not currently treated with an ESA, the compound be administered fortnightly as a subcutaneous or intravenous injection in order to increase haemoglobin, while for those already receiving ESAs being switched to Mircera receiving a monthly injection.

William M Burns, chief executive officer of the pharmaceuticals division of Roche, said: “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.”

He added that as a leading biotechnology firm, Roche aimed to develop pharmaceutical products marked by clinical differences for use in areas of currently unmet medical need.

In November 2006, Roche announced the results of two clinical trials of Mircera, with the studies showing the safety and efficacy of the compound as a treatment for anaemia.