AstraZeneca Lokelma recommended for approval in EU for patients with hyperkalaemia on stable haemodialysis

UK: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a dosing and administration label update for AstraZeneca's Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on stable haemodialysis.

The recommendation was based on data from the Phase IIIb DIALIZE trial, which showed a significant reduction in potassium levels pre-dialysis for patients receiving Lokelma, compared with placebo.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "Despite being on dialysis, many patients with the renal disease still have high potassium levels, which can be life-threatening if left untreated. This recommendation underscores the clinical value that Lokelma could provide to physicians and patients who are looking to normalize potassium levels between dialysis sessions."

In DIALIZE, 41% of patients receiving Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. This compared with 1.0% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement. The safety profile of Lokelma observed in DIALIZE was consistent with previous trials.

Lokelma is a highly selective, oral potassium-removing agent currently approved in the US, EU, Canada, Hong Kong, China, Russia, and Japan for the treatment of hyperkalaemia.

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Hyperkalaemia is characterized by high levels of potassium in the blood, generally classified as greater than 5mmol/l. Many people living with chronic kidney disease (CKD) have hyperkalaemia despite being on haemodialysis and often experience fluctuations in their potassium levels. Patients with high variability in potassium levels between dialysis sessions are at a significant risk of arrhythmias which can lead to cardiac arrest. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or heart failure with an estimated 700 million and 64 million people, respectively, living with each condition worldwide.

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