FDA approves AZ's Lokelma for hyperkalaemia

The FDA has revealed its decision to approve AstraZeneca’s oral potassium-removing agent Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.

The decision was based on the drug’s strong showing in Phase 3 trials, meaning it will now be available for use in the US.

Hyperkalaemia is a condition characterised by increased levels of potassium in the blood and can lead to cardiac arrest or even death. In severe cases, mortality rates stand at around 30% if not treated quickly. Risk of developing the disease rises significantly in patients with chronic kidney disease (CKD) or those who take common medications for heart failure such as renin-angiotensin-aldosterone system (RAAS) inhibitors.

"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," commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. "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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