Amgen Receives EC Approval

Amgen has received EC approval for Aranesp and Neulasta as oncology therapies.

The European Commission (EC) has approved both darbepoetin alfa (Aranesp/Nespo for the treatment of anaemia in adult cancer patients with solid tumours (non- haematological malignancies) receiving chemotherapy, and pegfilgrastim (Neulasta/Neupopeg) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Aranesp is a unique and powerful erythropoietic protein with greater in vivo activity and a longer half-life than other recombinant human erythropoietins, which allows for less- frequent dosing.

Neulasta, the only once-per-chemotherapy cycle stimulator of white blood cells, represents a major advance over current therapies in managing chemotherapy- induced infections.

“The approval of Aranesp by the European Commission represents a significant step forward for the treatment of anaemia in cancer patients receiving chemotherapy. The response obtained with Aranesp with less frequent dosing demonstrates well tolerated and highly effective therapy relative to current agents,” said Professor Robert Pirker, Vienna, Austria, primary investigator of the pivotal phase 3 study.

“This approval and the launch that follows will expand our commitment to dramatically improving the lives of patients with cancer. We are tremendously excited about bringing this major therapeutic advance to oncology patients throughout Europe,” said Keith Leonard, Vice President, Amgen Europe.

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