MirceraTreatment for Anemia Associated with Chronic Renal Failure
Update: Mircera - Now FDA Approved - November 14, 2007
Roche Submits Application with FDA to Market C.E.R.A.Submission Based On Results from Six Pivotal Phase III Clinical Trials with Dialysis and Non-Dialysis CKD Patients
NUTLEY, N.J., April 20, 2006 - Roche announced today it has submitted a Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA) to market C.E.R.A. for the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and not on dialysis.
C.E.R.A., an innovative investigational anti-anemia agent, is the first and only continuous erythropoietin receptor activator. This means that the activity of C.E.R.A. at the receptor sites involved in stimulating red blood cell production is different from what has been observed for erythropoietin, and this distinct molecular interaction is believed to have a role in providing targeted, stable and sustained control of anemia. It is the only anti-anemia treatment to have ever been studied at extended dosing intervals up to once every four weeks for its initial filing.
"The BLA filing for C.E.R.A. brings us another step closer to making this important therapy available to the millions of CKD patients in the United States who are at risk for the devastating effects of anemia," said George Abercrombie, president and chief executive officer, Hoffmann-La Roche Inc. "We believe C.E.R.A. will provide these CKD patients with sustained control of anemia and convenient extended dosing intervals."
The BLA submission is based on the largest clinical program ever undertaken for a drug treating renal anemia, with 10 clinical trials involving more than 2,700 patients from 29 countries. It included results from six Phase III trials of both intravenous and subcutaneous C.E.R.A. administered up to once every four weeks. Roche recently successfully completed the last two pivotal Phase III clinical trials for C.E.R.A. that examined correction of anemia in untreated patients on dialysis and not on dialysis.
The most frequently reported adverse events were hypertension, diarrhea, nasopharyngitis, headache and upper respiratory tract infection.
There are approximately 530,000 US CKD patients not on dialysis and 324,000 US patients on dialysis who suffer from anemia. Anemia refers to patients experiencing a lower than normal level of red blood cells or the hemoglobin in them. Hemoglobin enables red blood cells to carry oxygen throughout the body and therefore, when the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness, pale skin and other symptoms. Other serious clinical complications will appear as the body -- in particular, the heart -- works harder to compensate for the lack of oxygen.
Posted: April 2006
- FDA Approves Mircera: First Renal Anemia Treatment in the US with Monthly Maintenance Dosing - November 15, 2007
- Roche Receives Approvable Letter for Mircera in the United States - May 21, 2007
- Roche Offers the FDA Additional Mircera Data - December 15, 2006