The 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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Despite being on dialysis, many patients with renal disease still have high potassium levels, which can be life-threatening if left untreated. This recommendation underscores the clinical value that Lokelma could provide to physicians and patients who are looking to normalise potassium levels between dialysis sessions.”
In DIALIZE, 41% of patients receiving Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. This compared with 1.0% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement. The safety profile of Lokelma observed in DIALIZE was consistent with previous trials.1
Lokelma is a highly selective, oral potassium-removing agent currently approved in the US, EU, Canada, Hong Kong, China, Russia and Japan for the treatment of hyperkalaemia.