Takeda Pharmaceutical Co and partner Affymax say they intend to file their investigational anaemia drug Hematide during the first half of 2011.
Before year -end, the companies say they plan to discuss their registration strategy with the US Food and Drug Administration for Hematide (peginesatide) for the treatment of anaemia in chronic renal failure. Subject to feedback from the agency, they will pursue a New Drug Application for dialysis patients, “while continuing to evaluate the non-dialysis indication”.
Hematide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent, the same class as Amgen’s treatments Aranesp (darbepoetin alfa) and Epogen (epoetin alfa). In June, Takeda and Affymax reported data from its Hematide Phase III programme, which involved 2,609 patients, including two studies in non-dialysis patients (PEARL 1 and 2) and two others in dialysis patients (EMERALD 1 and 2).
The drug met the statistical criteria for non-inferiority in all four studies, when Hematide was compared to Epogen and Aranesp and darbepoetin, in correcting and/or maintaining haemoglobin. However in the PEARL trials, which evaluated correction and maintenance treatment of anaemia in non-dialysis patients, the frequency of cardiovascular events was higher in the Hematide group (21.6%) versus the comparator (17.1%).
Shares of Affymax sank after that news came out but the announcement of the planned filing sent it up almost 12%.