LOKELMA (sodium zirconium cyclosilicate) - Hyperkalaemia

The Committee deems that the clinical benefit of LOKELMA (sodium zirconium cyclosilicate) 5 g and 10 g powder for oral suspension is substantial in the MA indication.

Considering:

• demonstration of the efficacy of LOKELMA (sodium zirconium cyclosilicate) compared to
  placebo on the reduction and normalisation of serum potassium levels during the correction phase and the prevention of recurrences of hyperkalaemia during the maintenance phase;
• a safety profile judged to be acceptable despite the frequent occurrence of adverse events related to oedema;
• the insipid flavour of LOKELMA (sodium zirconium cyclosilicate) and the absence of sorbitol in its composition, which, according to expert opinion, could favour compliance and safety, respectively, in treated patients;
• a partially met medical need;

but in view of:

• the absence of a direct comparison with cation exchange resins;
• the absence of data concerning clinically relevant morbidity and mortality endpoints;
• the selection of a majority of patients included in clinical trials with serum potassium levels of 5.1 to 5.5 mmol/L;

the Committee deems that LOKELMA (sodium zirconium cyclosilicate) 5 g and 10 g powder for oral suspension provides a minor clinical added value (CAV IV) in the current care pathway for the treatment of hyperkalaemia in adults.