Swiss pharmaceutical company Roche has submitted a biological license application (BLA) to the U.S. FDA to market CERA for the treatment of anemia associated with chronic kidney disease in patients both on dialysis and not on dialysis.
The BLA submission was based on the largest clinical program ever undertaken for a drug treating renal anemia, which included six Phase III trials conducted in 29 countries and involving 2,400 patients. The studies investigated the efficacy of both intravenous and subcutaneous CERA administered up to once every four weeks.
"The U.S. filing for CERA is the next step along the path to making this important therapy available," said Eduard Holdener, global head of pharmaceutical development at Roche. "One of the primary endpoints we investigated was hemoglobin response and levels over time as we know that physicians find it challenging to keep patients' hemoglobin in a recommended target range We believe CERA's clinical profile is able to address this issue."
CERA is the only anti-anemia treatment to have been studied with long dosing intervals, up to once every four weeks, the company said.