AstraZeneca (AZ) has announced that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) for Lokelma (sodium zirconium cyclosilicate).
The FAD recommends the drug as an option for treating hyperkalaemia in adults, but only if used in emergency care for acute life-threatening hyperkalaemia alongside standard care or in outpatient care for people with persistent hyperkalaemia and chronic kidney disease stage 3b to 5 or heart failure. The indication is also only if they have a confirmed serum potassium level of at least 6.0 mmol/litre, are not taking an optimised dosage of renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia, and are not on dialysis.
The news comes shortly after AZ announced a statistically significant and clinically meaningful improvement from its Phase IIIb DIALIZE trial, investigating the efficacy and safety of the drug.
In the trial, 41.2% of patients with hyperkalaemia on stable haemodialysis receiving Lokelma maintained pre-dialysis normal potassium levels (4-5 mmol/L) on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy, compared to 1.0% of patients receiving placebo.
Professor David Wheeler, honorary consultant nephrologist and professor of kidney medicine at the Royal Free London NHS Foundation Trust, said that SZC “provides a new treatment option for patients who develop high potassium levels. It may allow long-term treatment for patients who develop recurrent high potassium levels, such as those with chronic kidney disease.”
Hyperkalaemia is the medical condition of elevated potassium levels in the blood. In severe cases, it may lead to cardiac arrest and death. There is an increased risk of developing hyperkalaemia in patients with chronic kidney disease and heart failure compared to the general population and in particular some patients who take cardio-renal medications.
Currently, dose reduction or discontinuation of RAASi therapy is often used by physicians to manage hyperkalaemia, even if this means removing medication with proven cardiovascular mortality benefits.