New FDA approval



AstraZeneca announced Monday the US Food and Drug Administration had approved its hyperkalaemia drug, a serious condition associated with elevated levels in the blood. The US Food and Drug Administration’s approval of Lokelma, an oral potassium-removing agent, was supported by data from three double-blind, placebo-controlled trials and two open-label trials showing the drug helped to normalise potassium levels. ‘The consequences of hyperkalaemia can be very serious and it’s reassuring for treating physicians that Lokelmahas demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors,’ said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. ‘This FDA 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,’ said Steven Fishbane, MD, Professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York. Story provided by