EU approves label update for AZ' Lokelma
European regulators have approved a label update 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 haemodialysis.
The decision rides on the back of findings from the Phase IIIb DIALIZE trial, which AZ says is 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 marks the first label update for Lokelma in Europe following its EC approval in 2018 to treat adults with hyperkalaemia, and it follows a green light by the US Food and Drug Administration for the new dosing regimen last week.
4th May 2020