AstraZeneca’s hyperkalaemia therapy receives CHMP recommendation

AstraZeneca has announced that its new treatment for hyperkalaemia has been recommended for European regulatory approval.

The sodium zirconium cyclosilicate therapy ZS-9 has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for approval in this indication based on its strong performance in clinical trials.

Hyperkalaemia is a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases. It occurs often in patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death.

Data from three double-blind placebo-controlled trials and one ongoing 12-month open-label study in adults with hyperkalaemia, representing more than 1,600 patients treated to date, have shown that ZS-9 is able to significantly reduce blood serum potassium to normal levels.

The company said: "As current therapy options are limited, sodium zirconium cyclosilicate has the potential to address a longstanding unmet need for the fast, safe and effective long-term treatment of hyperkalaemia."

ZS-9 is also currently also under regulatory review in Australia and the US, with decisions expected in the first half of 2017.

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