Amgen Inc, one of the leading biotechnology companies, announced that the European Commission had approved expanded marketing authorization for Aranesp (darbepoetin alfa) in the European Union (EU) following the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on July 29, 2004.
This decision allows extended Aranesp dosing intervals of once-every-three-weeks in the treatment of anaemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month Aranesp administration in the treatment of anaemia in chronic kidney disease (CKD) patients not on dialysis, release from Amgen said.
"This is an important advance for patients, healthcare providers and caregivers across the EU," said Professor Carsten Bokemeyer, Department of Haematology, Oncology and Immunology, Tuebingen University Hospital, Germany. He added, "Aranesp has a unique pharmacokinetic profile compared to conventional rHu-EPO molecules, which means it can be administered less frequently than other erythropoietins. Extended dosing allows healthcare providers to administer Aranesp to adult cancer patients on chemotherapy just once-every-three-weeks, simplifying the treatment process and providing patients the protection they need to manage their anaemia."
"Extended dosing makes anaemia management in CKD much more convenient," Fernando Carrera of Eurodial Dialysis Clinic, Leiria, Portugal said adding, "Patients with progressive renal failure often visit their physicians on a monthly basis. Now, the monthly administration of Aranesp can be coordinated with these visits, simplifying anaemia management therapy effectively to maximize patient benefits."
Anaemia is a common and serious side effect of CKD and cancer chemotherapy. Anaemia management with other erythropoietic therapies requires patients to receive treatment more frequently than with Aranesp. As well as consuming the resources of healthcare systems and professionals, this puts a strain on patients themselves who must cope with already demanding treatment regimens. Today's European Commission decision should greatly relieve these burdens.
Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anaemia associated with chronic renal failure in adults and paediatric subjects 11 years of age or older. In 2002, the European Commission approved Aranesp for the treatment of anaemia in adult cancer patients receiving chemotherapy with solid tumours. This patient population was subsequently expanded in 2003 to include all adult cancer patients with non-myeloid malignancies receiving chemotherapy.