Posted by Michael Wonder on 27 Apr 2020
Lokelma US label updated to include dosing guidance for the treatment of hyperkalaemia in patients with end-stage renal disease on haemodialysis
27 April 2020 - Label update is based on data from Phase IIIb DIALIZE trial
Today, the US FDA 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 chronic haemodialysis.
The approval by the US FDA 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.
