UK – NICE expands draft recommendation for Lokelma

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…