US regulators have approved a label update in the US for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on stable hemodialysis.

The approval was based on positive results from the Phase IIIb DIALIZE trial, the first-ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis.

Data showed that a significantly higher proportion of patients in the Lokelma group (41.2%) met the primary endpoint and were classified as responders compared to patients in the placebo group (1.0%).

This label update – the first for Lokelma in the US following its approval in 2018 to treat adults with hyperkalaemia – now includes a dosing regimen for a starting dose of 5g daily given on non-dialysis days and a starting dose of 10g once daily on non-dialysis days in patients with certain serum potassium levels.