The Food and Drug Administration (FDA) has granted Fast Track designation to sodium zirconium cyclosilicate to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia.
Sodium zirconium cyclosilicate is a nonabsorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium. It increases fecal potassium excretion by binding potassium in the lumen of the gastrointestinal (GI) tract. Binding of potassium reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels.
AstraZeneca is investigating the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia in the phase 3 DIALIZE-Outcomes study (ClinicalTrials.gov Identifier: NCT04847232).
“The DIALIZE-Outcomes trial is the first ever cardiovascular outcomes trial with a potassium binder in hemodialysis and has the potential to transform standard of care for these patients,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.
Sodium zirconium cyclosilicate is currently marketed under the brand name Lokelma and is approved for the treatment of hyperkalemia in adults.
Lokelma® granted Fast Track designation in the US to reduce cardiovascular outcomes in patients on chronic hemodialysis with hyperkalemia. News release. AstraZeneca. Accessed November 17, 2021. https://www.businesswire.com/news/home/20211117006015/en/LOKELMA%C2%AE-Granted-Fast-Track-Designation-in-the-US-to-Reduce-Cardiovascular-Outcomes-in-Patients-on-Chronic-Hemodialysis-With-Hyperkalemia.