EMA accepts MAA for Hematide (Takeda) for Anaemic adults on dialysis

The EMA has accepted Hematide (peginesatide), from Takeda, for assessment for a Marketing Authorisation Application (MAA) for the treatment of symptomatic Anaemia associated with Chronic Kidney Disease (CKD) in adult patients on dialysis. The submission was supported mainly by data from two Phase III studies (EMERALD 1 and 2) that evaluated the drug's efficacy and safety, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed three times per week, in maintaining hemoglobin (Hb) levels. The EMERALD studies were part of the largest Phase III clinical program to support the initial registration of an ESA, enrolling more than 2,600 patients, including approximately 1,600 dialysis patients. The EMERALD findings suggested that once-monthly Hematide was similar to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia. In addition the two groups had a similar safety profile.