CHMP recommends ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.- AstraZeneca.
AstraZeneca announced that 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, a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases.
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, sodium zirconium cyclosilicate (oral suspension) significantly reduced blood serum potassium to normal levels (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. In these trials, sodium zirconium cyclosilicate was shown to significantly lower serum potassium levels quickly and effectively in patients with acute and chronic hyperkalaemia.
The condition occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure, both key strategic areas of focus for AstraZeneca, and may lead to cardiac arrest and death; with mortality being up to 30% in patients with severe hyperkalaemia if not treated rapidly1. As current therapy options are limited, sodium zirconium cyclosilicate has the potential to address a long-standing unmet need for the fast, safe and effective long-term treatment of hyperkalaemia.
Comment: RLY 5016 (patiromer) (now Veltassa) from Relyspa Inc. has FDA approval on 22 October 2016 for hyperkalaemia but carries a black box warning.
Comment: ZS-9 is currently also under regulatory review in Australia and by the FDA in the US, with decisions expected in the first half of 2017.
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