New US label for hyperkalemia therapy Lokelma

Based on positive results from the Phase IIIb DIALIZE trial, the US Food and Drug Administration has approved a label update Lokelma (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis, from Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN), whose shares were up more than 1% at £82.88 by late morning.

The DIALIZE trial showed that a significantly higher proportion of patients in the Lokelma group (41.2%) met the primary endpoint and were classified as responders (maintained serum potassium 4-5mmol/L during at least three out of four hemodialysis sessions after the long interdialytic interval [LIDI] of the last four weeks of treatment and did not require urgent rescue therapy) compared to patients in the placebo group (1.0%), making it a statistically significant (P<0.001) and clinically meaningful improvement. Rescue therapy was defined as any urgent therapeutic intervention considered necessary to reduce serum potassium for severe hyperkalemia (serum potassium >6.0 mmol/L). The safety profile of Lokelma observed in DIALIZE was consistent with previous trials.

The label update now includes a dosing regimen for patients on chronic hemodialysis with a starting dose of 5g once daily on non-dialysis days and a starting dose of 10g once daily on non-dialysis days in patients with serum potassium greater than 6.5mmol/L.