US regulators have finally issued a green light for AstraZeneca’s Lokelma as a treatment for hyperkalaemia - elevated potassium levels in the blood - in adult patients.
The treatment, an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions, was previously rejected by twice by the regulator largely because of manufacturing issues.
Risk of developing hyperkalaemia 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.
In clinical trials, the median time to achieving normal potassium levels for patients with hyperkalaemia taking the Lokelma was 2.2 hours, with 98 percent achieving normal levels within 48 hours from baseline.
Steven Fishbane, professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York, said the approval “represents an exciting milestone, as it stands to deliver a rapid, effective and generally well-tolerated treatment option to patients suffering from hyperkalaemia in the US.”
AZ picked up rights to the drug via its acquisition of ZS Pharma in 2015, and it was approved for use in the EU earlier this year.