Discussing how a recently approved label update for sodium zirconium cyclosilicate impacts the treatment armamentarium of clinicians.
Thanks to a recent label update by the US Food and Drug Administration, patients with end-stage renal disease undergoing hemodialysis have a new treatment option for hyperkalemia in sodium zirconium cyclosilicate (Lokelma).
Initially approved for the treatment of adults with hyperkalemia in 2018, approval of the label update is based on data from the phase 3b DIALIZE trial, which was the first randomized, placebo-controlled trial to evaluate a potassium binder in patients on stable hemodialysis. Results of the trial indicated a greater proportion of patients met the study’s primary endpoint and were classified as responders in the sodium zirconium cyclosilicate group versus those re ceiling placebo.
“More than 500,000 patients in the US are living with dialysis-dependent end-stage renal disease and could be at risk for dangerously high levels of potassium. With this FDA approved update, the LOKELMA label now includes important dosing guidance for treating hyperkalemia in patients on hemodialysis,” said Mene Pangalos, PhD, executive vice president of BioPharmaceuticals Research and Development at AstraZeneca, in a statement.
Overall, results of DIALIZE demonstrated 41.2% of patients receiving sodium zirconium cyclosilicate met the primary end point and were considered responders compared to just 1.0% of the placebo group. The latest label update, which was announced in late April 2020, includes a dosing regimen of 5 grams once daily on non-dialysis days and 10 grams per day once daily on non-dialysis days in those with serum potassium greater than 6.5 mmol/L.
AstraZeneca also noted the European Commission (EC) has also approved a dosing and administration label update in the EU for Lokelma to include patients with hyperkalemia on stable hemodialysis.
To learn more about how this label update approval impacts the treatment armamentarium of clinicians, HCPLive® sat down with Kerry Cooper, MD, Vice President of US Medical Affairs of Renal Cardio at AstraZeneca, and that conversation is the subject of the latest HCPLive House Call.