Roche submits more data for Mircera BLA

Swiss drug major Roche has submitted additional data to the Food and Drug Administration to support the Biologic License Application for Micera, its continuous erythropoietin receptor activator. The firm says the data provide "as comprehensive an understanding of Mircera as is possible" to assist the FDA in completing the review, and the move triggers a three-month extension to the agency's action date.

Roche is seeking an indication for the agent in the treatment of anemia associated with chronic kidney disease 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.