22 May 2018
The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9 – AstraZeneca’s drug for the treatment of adults with hyperkalaemia.
A serious condition, hyperkalaemia is characterised by elevated potassium levels in the blood and can lead to cardiac arrest and death. It is associated with cardiovascular, renal, and metabolic diseases – the risk of hyperkalaemia increases significantly for patients with chronic kidney disease, and those who take common medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.
To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise its effectiveness and increase the risk of death.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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.’
Lokelma is a highly-selective, oral potassium-removing agent. The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label trials, which showed that for patients receiving Lokelma the onset of action was at 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours from baseline. The treatment effect was maintained for up to 12 months.
The announcement comes two months after the European Commission granted marketing authorisation for Lokelma in the EU.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the fields of oncology, cardiovascular, renal and metabolism, and respiratory.