EU approves AZ’ potassium binder for hyperkalaemia

Hyperkalaemia is characterised by elevated potassium levels in the blood. Risk of developing the condition increases significantly for patients with chronic kidney disease and for those who take common life-saving medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, but this can compromise cardio-renal outcomes and increase the risk of death, the firm noted.

Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) is an insoluble, non-absorbed compound with a structure designed to preferentially capture potassium ions.

In clinical trials, the median time to achieving normal potassium levels for patients with hyperkalaemia taking the drug was 2.2 hours, with 98 percent achieving normal levels within 48 hours from baseline.

"The consequences of hyperkalaemia can be serious, even life-threatening, and can occur in patients either with chronic kidney disease or as a result of taking some medications for heart failure," said Elisabeth Björk, head of Cardiovascular, Renal and Metabolism, Global Medicines Development, at AZ.

"The approval of Lokelma "addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia."

Lokelma is still under review in the US, having previously been rejected by the US Food and Drug Administration because of manufacturing issues.

AZ picked up rights to the drug via its acquisition of ZS Pharma in 2015.

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