ROCHE SUBMITS ADDITIONAL MIRCERA DATA

Roche announced it has submitted additional data to the FDA to support its biologic license application (BLA) for Mircera. The data are intended to provide as comprehensive an understanding of Mircera as is possible to assist the FDA in completing the review process. As a result of this action, the FDA has granted Roche a three-month extension to the review period.

Roche is seeking an indication for Mircera in the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and not on dialysis. The BLA submitted to the FDA is based on data from all six studies that comprise the Phase III clinical program. This included treating anemia in previously untreated patients and maintaining hemoglobin after conversion from epoetin alfa/beta or darbepoetin alfa. The program consisted of two treatment/correction and four conversion/maintenance studies of both intravenous and subcutaneous Mircera at extended administration intervals of up to once monthly.

The investigational anti-anemia agent is the first continuous erythropoietin receptor activator, according to Roche. 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 U.S. and Europe in April seeking approval for use of the treatment in anemia associated with CKD in patients on dialysis and not on dialysis.