NUTLEY, N.J., April 20 (UPI) -- Roche said Thursday it has filed with the FDA for approval of C.E.R.A. for the treatment of renal anemia.
The company said it based the filing on the results of six clinical studies of the drug in both dialysis and non-dialysis patients with chronic kidney disease.
"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 of 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," he said.
Roche said its drug is the "first and only continuous erythropoietin receptor activator," meaning the drug's activity at the receptor sites involved in stimulating red-blood-cell production is different from what has been observed for erythropoietin, giving the treatment enhanced anemia control.
The company added that the drug candidate is the only anti-anemia treatment to be tested at extended dosing intervals up to once every four weeks for its initial filing. Roche noted that it study was also the largest study ever of a therapy for renal anemia, with 10 clinical trials involving more than 2,700 patients from 29 countries.