AstraZeneca has updated use of Lokelma based on data from Phase IIIb DIALIZE trial.
WILMINGTON, Del.–(BUSINESS WIRE)–Today, the US Food and Drug Administration (FDA) approved a label update in the US for AstraZeneca’s LOKELMA® (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis.
The approval by the US FDA was based on positive results from the Phase IIIb DIALIZE trial, the first ever randomized, placebo-controlled trial to evaluate a potassium binder in patients on stable hemodialysis. 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 4-5 mmol/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.
LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. This is the first label update for LOKELMA in the US following its FDA approval in 2018 to treat adults with hyperkalemia. The label update now includes a dosing regimen for patients on chronic hemodialysis with a starting dose of 5 g once daily on non-dialysis days and a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mmol/L.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “More than 500,000 patients in the US are living with dialysis-dependent end-stage renal disease and could be at risk for dangerously high levels of potassium. With this FDA approved update, the LOKELMA label now includes important dosing guidance for treating hyperkalemia in patients on hemodialysis.”
LOKELMA is currently approved in the US, EU, Canada, Hong Kong, China, Russia and Japan for the treatment of patients with hyperkalemia. LOKELMA recently received a positive opinion from The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on a dosing and administration label update to include patients with hyperkalemia on stable hemodialysis. A final decision is expected from the European Commission in the near-future.