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FDA approves Lokelma for treatment of adults with hyperkalemia
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The FDA recently announced approval of Lokelma, formerly ZS-9, for the treatment of hyperkalemia in adults.
“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,” Sean Bohen, chief medical officer at AstraZeneca, said in a press release from the company. “The consequences of hyperkalemia can be 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 [renin-angiotensin-aldosterone system] RAAS inhibitors.”
Lokelma is a highly selective, oral potassium-removing agent. The FDA approval comes on the back of Lokelma receiving authorization from the European Commission for the treatment of hyperkalemia in adult patients and it is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials.
The onset of action was at 1 hour, the median time to achieving normal potassium levels in the blood was 2.2 hours and 92% of patients achieved normal potassium levels within 48 hours from baseline, according to data from one clinical trial. Lokelma was effective in lowering potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.
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