AMGEN'S ARANESP DID NOT MEET ENDPOINT IN ANEMIA STUDY

Amgen has sent a letter informing healthcare professionals of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions in cancer patients who have anemia that is not due to concurrent chemotherapy. In addition, this study showed higher mortality in patients receiving Aranesp (darbepoetin alfa).

In the Phase III study, Aranesp was compared with placebo in patients with active malignant disease not receiving chemotherapy or radiation therapy. This study was designed to establish the effectiveness of Aranesp in this new indication and failed to meet its primary endpoint of reducing red blood cell transfusions in the Aranesp treatment group. Also, more deaths occurred in the Aranesp treatment group when compared with the placebo group.

The treatment period of the study was 16 weeks. A total of 989 patients with hemoglobin less than 11 g/dL, with active cancer and not receiving myelosuppressive chemotherapy or radiotherapy were enrolled. Additional information on safety and effectiveness will be obtained from data from a 16-week extension study in which randomized treatment with Aranesp or placebo was continued.

The final analysis of the initial 16-week treatment period did not show a statistically significant effect on the primary efficacy endpoint, with an incidence of red blood cell transfusions of 24 percent in the placebo group versus 18 percent in the Aranesp group.

Aranesp is currently approved for the treatment of patients with anemia caused by cancer chemotherapy. The company emphasizes in the letter that Aranesp should be used only in accordance with its approved product labeling.