Roche submits CERA MAA to EMEA

Switzerland-based drug major Roche says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) relating to CERA, its novel treatment for chronic kidney disease associated anemia. The drug, which is a continuous erythropoietin receptor activator, is believed to enable stable, targeted control of the condition via a novel molecular interaction at receptor sites.

The submission is based on data from a Phase III trial that the firm launched in 2004 which established the product's efficacy and safety, as well as five other programs conducted at a variety of research centers across the world. In total the drug has been assessed in more than 2,400 patients who initially received it as a corrective therapy once every two weeks, before moving to four-weekly dosing when disease control had been established.The submission follows a similar filing with the US Food and Drug Administration late last month (Marketletter April 20).