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CHMP positive opinion for ZS-9 in hyperkalaemia
CHMP positive opinion for ZS-9 in hyperkalaemia.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8210X AstraZeneca PLC 24 February 2017 \n\nThis announcement contains inside information\n \n24 February 2017 12:30 GMT\n \nZS-9 (sodium zirconium cyclosilicate) RECEIVES POSITIVE CHMP OPINION FOR THE TREATMENT OF HYPERKALAEMIA \n \nAstraZeneca today 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. \n \nThe 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. \n \nResults 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.\n \nIn these trials, sodium zirconium cyclosilicate was shown to significantly lower serum potassium levels quickly and effectively in patients with acute and chronic hyperkalaemia.1,2\n \nThe 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.2,3\n \nThe 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.\n...