Selective potassium-removing agent receives positive CHMP opinion for treatment hyperkalaemia
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia. ZS-9 is an insoluble, non-absorbed zirconium silicate compound and acts as a highly selective potassium-removing agent.
The recommendation is based on data from three double-blind placebo-controlled trials and one ongoing 12-month open-label trial in adults with hyperkalaemia, representing over 1,600 patients treated to date.
Results from a pivotal Phase III study showed that in patients with hyperkalaemia, an oral suspension of ZS-9 significantly reduced blood serum potassium to normokalaemia within 48 hours, which was maintained during 12 days of maintenance therapy. Normal levels of potassium in the blood serum were also achieved within 48 hours in an additional study, with a higher proportion of patients maintaining normokalaemia for up to 28 days on treatment versus placebo.
Hyperkalaemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death; with mortality being up to 30% in patients with severe hyperkalaemia if not treated rapidly. Current therapy options are limited.
The CHMP’s opinion will now be advanced to the European Commission (EC) for adoption of a decision on EU-wide marketing authorisation of the medicine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.