GSK Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Daprodustat for Symptomatic Anaemia Associated with Chronic Kidney Disease
- The EMA’s CHMP has issued a positive opinion recommending authorization of daprodustat (hypoxia-inducible factor prolyl hydroxylase inhibitor) for symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis
- The opinion was based on the P-III (ASCEND) program in dialysis patients incl. (ASCEND-D), (ASCEND-ID) & (ASCEND-TD) trials evaluating daprodustat vs erythropoiesis-stimulating agent therapy. The trial met its primary efficacy and safety EPs & showed that daprodustat improved or maintained Hb within target levels (10-11.5 g/dL)
- The primary safety analysis of the ITT population showed that daprodustat achieved non-inferiority of MACE over ESA control. Jesduvroq (daprodustat) was approved in the US for anaemia due to CKD in adults
Ref: GSK | Image: GSK
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