Mircera

Treatment for Anemia Associated with Chronic Renal Failure

Update: Mircera - Now FDA Approved - November 14, 2007

Roche Offers the FDA Additional Mircera Data

FDA accepts and grants three month extension to the review

NUTLEY, N.J., December 15, 2006 -- Roche today announced that it has submitted additional data to the FDA to support its Biologic License Application (BLA) for Mircera. These data offered 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.

"The newly available Mircera data that we have proactively submitted will help to give the FDA additional clarity in key areas that the FDA is monitoring with already available anti-anemia agents," said Eduard Holdener, Global Head Pharma Development. He added, "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."

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 (Hb) 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.

About Mircera

Roche's innovative investigational anti-anemia agent 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 United States and the European Union in April of this year seeking approval for use of the treatment in anemia associated with CKD in patients on dialysis and not on dialysis.

Safety Information

In clinical trials, the most commonly reported adverse events were hypertension, diarrhea, nasopharyngitis, headache, and upper respiratory tract infection. Erythropoetic therapies may increase the risk of cardiovascular and other thrombotic events. Pure Red Cell Aplasia (PRCA) has been observed in patients treated with erythropoietin therapy, however, PRCA has not been observed with Mircera in clinical trials to date.

Source: Roche

Posted: December 2006

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