“We want to ensure that our application to the FDA is as robust as possible in an evolving regulatory environment and we are confident that the additional data submitted will facilitate a positive review of Mircera,” said Eduard Holdener, global head, Pharma Development.
The FDA has granted the extension so it has more time to review the new data. Roche is seeking an indication for Mircera in the treatment of anemia associated with chronic kidney disease including patients on dialysis and not on dialysis. The biologics license application submitted to the FDA is based on data from all six studies that comprise the phase III clinical program.
Mircera is the first continuous erythropoietin receptor activator. Its activity at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs.
Roche filed applications with the regulatory authorities in the US and the European Union in April of this year.