United Kingdom-based AstraZeneca has received approval from The US Food and Drug Administration (FDA) for its Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, intended for the treatment of hyperkalaemia in adults, it was reported yesterday.
The product is a highly selective, oral potassium-removing agent. It has received approval based on the product receiving authorisation from the European Commission for the treatment of hyperkalaemia in adult patients and it is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials.
AstraZeneca chief medical officer and global medicines development executive vice president, Sean Bohen, said, '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 hyperkalaemia. The consequences of hyperkalaemia 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 inhibitors.'
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