The extension data, presented for at the American Society of Nephrology 38th annual meeting, mirror earlier results in dialysis patients, suggesting that CERA provides consistent anti-anemia activity in a broad spectrum of patients with chronic kidney disease (CKD). Roche has now initiated an extensive phase III clinical program into the drug.
Anemia (inadequate hemoglobin) is a common comorbidity in CKD patients but is under-diagnosed and under-treated in the early, pre-dialysis stages of this progressive illness. The need to treat anemia in this patient population is gaining recognition as anemia has been linked to the development of cardiovascular disease and acceleration of the progression of kidney disease.
“CERA provided consistent and reliable hemoglobin levels in a controlled manner that resembles how the body naturally regulates itself,” said lead investigator Dr Robert Provenzano of the St John Hospital and Medical Center, Detroit. “The current guidelines for anemia management, including those in the US, recommend that CKD patients be kept in an optimal range between 11 to 12 g/dL and CERA achieved this at extended dosing intervals.”
Roche is currently the subject of a lawsuit being brought against it by the biotechnology company Amgen which alleges that CERA infringes a number of patents owned by the company covering erythropoietin (EPO) which forms the bases of its own anemia treatment, Epogen.