I read the article. In my opinion, the authors serious questioned the reliability of the hazard ratios of both the EMERALD and PEARL peginesatide studies due to the small numbers of patients enrolled and the fact that none of the patients were ESA naive. Their bottom line conclusions: (a) test size too small to disclose the anaphylaxis risk of .02%; (b) proven, safer alternative ESAs available to treat these patients; (c) convenience benefits of peginesatide dimished for dialysis CKD patientsresults are unknown about patients who develop antibodies to peginesatide; (d) peginesatide would beneficial in the rare patient who develops red blood cell aplasia as a result of antibodies to recombinant ESA.
But we already knew those results from my earlier posts. Should the FDA be persuaded by this article, it does not portend well for the return of Omontys to market absent the results of substantial new tests. There is a financial disclosure that accompanies the article: ["Dr Parfrey is an executive committee
member of TREAT, which is funded by Amgen, and has received remuneration from Amgen for traveling and speaking. DrsWarden and Barrett declare that they have no relevant financial interests."]