Posted by Michael Wonder on 17 Nov 2021
Lokelma granted fast track designation in the US to reduce cardiovascular outcomes in patients on chronic haemodialysis with hyperkalaemia
17 November 2021 - AstraZeneca has been granted fast track designation in the United States for the development of Lokelma (sodium zirconium cyclosilicate) to reduce arrhythmia-related cardiovascular outcomes in patients on chronic haemodialysis with recurrent hyperkalaemia.
The designation is based on the potential of Lokelma to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need. This is being investigated in the ongoing Phase3 DIALIZE-Outcomes trial.
