Lokelma recommended for approval in EU for patients with hyperkalaemia on stable haemodialysis
Label update is based on data from Phase IIIb DIALIZE trialThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on stable haemodialysis. The recommendation was based on data from the Phase IIIb DIALIZE trial, which showed a significant reduction in potassium levels pre-dialysis for patients receiving Lokelma, compared with placebo.[1] Mene Pangalos, Executive Vice