Amgen publishes Phase 3 study results of Aranesp
June 14, 2017
A post hoc analysis indicates that there were no significant differences between treatment arms in the incidence of cancer or of all-cause deaths in patients who developed cancer during the trial. However, this analysis also showed an excess in overall mortality among patients in the Aranesp arm with a history of cancer. This finding requires further investigation.
"ESAs were originally approved to raise red blood cell levels and to reduce the need for transfusions. In the TREAT study, we sought to demonstrate that, beyond these benefits, ESA therapy reduces cardiovascular morbidity and mortality. This hypothesis is not supported by the data," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "As the first, large-scale placebo-controlled study to examine the use of anemia therapy in diabetic CKD patients not on dialysis, the TREAT results demonstrated that in many diabetic CKD patients not on dialysis with moderate anemia, the risk of treatment to a target hemoglobin level of 13 g/dL will exceed the benefit of reducing the need for transfusions."
Amgen has shared this information with global regulatory authorities and anticipates that the TREAT results will be included in labeling once discussions are complete.
SOURCE Amgen