18 May 2018 - Lokelma provides a rapid and sustained treatment for hyperkalaemia, a condition with high unmet need.
AstraZeneca today announced that the US FDA has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalaemia in adults.
Data from one clinical trial showed that for patients receiving Lokelma, the onset of action was at one 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. Lokelma should not be used as an emergency treatment for life-threatening hyperkalaemia. Lokelma was effective in lowering potassium levels in patients with CKD, HF, diabetes and those taking RAAS inhibitors. The most common adverse event was mild to moderate oedema at 6% with the recommended dose of 10 g once daily (range of 4 - 16% with 5 -15 g daily).