Positive CHMP opinion on use of potassium binder in patients with hyperkalemia on dialysisNews - Apr. 6, 2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a label update for sodium zirconium cyclosilicate to include patients with hyperkalemia on stable hemodialysis. This opinion is based on results from the phase III DIALIZE trial, which showed a reduction in potassium levels before dialysis in patients randomized to sodium zirconium cyclosilicate compared to placebo.
The DIALIZE trial is a randomized, placebo-controlled, multicenter, double-blinded trial that evaluated the efficacy of the potassium binder sodium zirconium cyclosilicate compared to placebo in 196 patients with hyperkalemia on stable hemodialysis. Patients were randomized to receive sodium zirconium cyclosilicate or placebo once daily on non-dialysis days for 8 weeks, including a 4-week dose adjusting phase and a 4-week evaluation phase on stable dose. Pre-dialysis potassium levels were maintained in 41% patients in the sodium zirconium cyclosilicate group on at least 3 out of 4 dialysis treatments after the interdialytic interval compared to 1.0% in the placebo group. Sodium zirconium cyclosilicate appeared to be safe, as was seen in previous trials. Full results of the DIALIZE trial were published in September 2019 in the Journal of the American Society of Nephrology.
Sodium zirconium cyclosilicate is formulated as a powder for oral suspension. It acts as a highly selective potassium-removing medication. It is administered orally, odorless, tasteless and stable at room temperature.
It is currently approved in the US, EU, Canada, Hong Kong, China, Russia and Japan for treatment of hyperkalemia.