Cochrane meta-analysis confirms ESA AE profile

Amgen has received a summary of preliminary results from the Cochrane Collaboration's independent meta-analysis of patient-level data from previously-conducted clinical studies evaluating erythropoiesis-stimulating agents in cancer patients. The US biotechnology giant has submitted the summary to regulatory authorities, including the Food and Drug Administration and the European Medicines Agency (EMEA).

"The Cochrane Collaboration's analysis corroborates important information already reflected in the recently-revised ESA labeling," said Roger Perlmutter, executive vice president of R&D at Amgen. Sales of the firm's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), which in 2006 generated revenues of $6.6 billion, dropped to $2.0 billion last year on safety concerns (Marketletters passim).

The analyses were based on 53 studies involving 13,933 patients. None of these trials utilized ESAs according to current guidance. Amgen noted that the overall survival results corroborate a 2006 review by the Cochrane Collaboration, which is included in the Warnings section of the current US prescribing information.