Roche submits CERA BLA to US FDA

Swiss drug major Roche has submitted a Biological License Application to the US Food and Drug Administration to market CERA for the treatment of anemia associated with chronic kidney disease including patients on dialysis and not on dialysis. According to Basel-headquartered firm, the investigational drug is the first and only continuous erythropoietin receptor activator and Roche says that this distinct molecular interaction is believed to have a role in providing targeted, stable and sustained control of anemia.