Amgen Inc announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to expand the marketing authorization for Aranesp (darbepoetin alfa) in the European Union (EU).
The CHMP opinion recommends authorization of once-every-three-week Aranesp administration in the treatment of anaemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month administration in the treatment of anaemia in chronic kidney disease (CKD) patients not on dialysis.
"With the majority of cancer patients receiving chemotherapy on a 21-day cycle, the opportunity to receive Aranesp once every three weeks is a significant added benefit for patients and their physicians. Once approved, patients with CKD not on dialysis, who often visit their physician monthly, can greatly benefit from an up to once-monthly Aranesp treatment regimen," Beth Seidenberg, senior vice president of development and chief medical officer at Amgen said adding, "Aranesp's ability to effectively correct haemoglobin with less frequent dosing than other erythropoietic agents can simplify anaemia management for people with cancer receiving chemotherapy or those afflicted with CKD."
Recommendations from the CHMP are typically endorsed by the European Commission for marketing authorization within three to four months. When approved, Aranesp will be the first and only erythropoietic stimulating protein approved in the EU for once-every-three-week and once-per-month dosing, company said in a release.
In Europe, marketing authorization for Aranesp was granted in 2001 for the treatment of anaemia associated with kidney disease. The authorization was expanded in 2002 to include patients with solid tumours and chemotherapy-induced anaemia. In 2003, the approval was granted to include cancer patients with lymphoproliferative diseases. Thus, Aranesp is indicated for the treatment of anaemia in adult cancer patients with non-myeloid malignancy who are receiving chemotherapy.
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anaemia treatment with the discovery of recombinant erythropoietin, epoetin alfa, which is currently marketed in the US by Amgen as Epogen (Epoetin alfa) and by Ortho Biotech Products, LP, as Procrit (Epoetin alfa). Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule resulting in more activity with the added benefit of less-frequent administration.
Aranesp was approved by the US FDA in September 2001 for the treatment of anaemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anaemia in patients with non-myeloid malignancies.