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The new drug offers rapid and sustained control of patients’ potassium levels.
FDA has approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for treating hyperkalemia, a condition characterized by elevated potassium levels in the blood, and associated with cardiovascular, renal, and metabolic diseases.
In March 2018, the European Commission approved use of the drug, a highly selective oral potassium-removing agent.
“We are pleased by today’s FDA approval of Lokelma, as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalemia. The consequences of hyperkalemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes, and those taking RAAS [renin-angiotensin-aldosterone system] inhibitors,” said Sean Bohen, executive vice president of global medicines development, and chief medical officer at AstraZeneca, in a company press release:
“This FDA approval represents an exciting milestone, as it stands to deliver a rapid, effective and generally well-tolerated treatment option to patients who suffer from hyperkalemia in the [United States],” Steven Fishbane, MD, professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York, said in the press release.
The risk of hyperkalemia increases significantly for patients with chronic kidney disease and for those who take common medications for heart failure, such RAAS inhibitors, which can increase potassium in the blood, according to the company. To help prevent the recurrence of hyperkalemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death, the company reports.