AstraZeneca have announced that the European Commission (EC) has granted marketing authorisation for Lokelma for the treatment of adult patients with hyperkalaemia. Hyperkalaemia can be a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. Hyperkalaemia presents in 1-10% of hospitalisations globally and can result in cardiac arrhythmia, cardiac arrest and sudden death.
Compared to the general population, there is an increased risk of hyperkalaemia in patients with chronic kidney disease (CKD) and those who take common life-saving 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; however, this can compromise cardio-renal outcomes and increase the risk of death.
Sodium zirconium cyclosilicate is a highly-selective, oral potassium-removing agent. The EC approval is based on data from three double-blind, placebo-controlled and one open-label trial where patients with hyperkalaemia were treated for up to 12 months. All four studies showed that sodium zirconium cyclosilicate was effective at reducing serum potassium levels and ZS005 demonstrated sustained potassium control for up to one year. In all trials, in total involving more than 1,700 patients, the most common adverse reactions were hypokalaemia and oedema-related events.
Commenting on the approval, Professor David Wheeler, Centre for Nephrology at University College London, said: “The way we treat hyperkalaemia has changed very little over the last 50 years. Short-term treatments provide temporary relief, and longer-term management can require the patient to stop taking other important medicines and adopt a strict, low-potassium diet.”
Laurent Abuaf, Country President, AstraZeneca UK, said “Approximately 200,000 patients are diagnosed with hyperkalaemia every year in the UK. They are likely to already have other serious health concerns and their doctors face a balancing act to manage hyperkalaemia as a potentially life-threatening condition. As a UK headquartered company that invests two billion pounds in British R&D and has more than 10% of our global workforce in this country, we are following the science to support the holistic care these patients require.”