Sodium Zirconium Cyclosilicate Gets Positive EU Marketing Recommendation

Larry Hand

February 24, 2017

LONDON, UK — The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval in the European Union (EU) of sodium zirconium cyclosilicate (ZS-9, AstraZeneca) for treatment of hyperkalemia, according to a news release from AstraZeneca[1].

The recommendation by CHMP, an arm of the European Medicines Agency (EMA), is based on results of three double-blind placebo-controlled clinical trials and one ongoing open-label trial in adults with acute and chronic hyperkalemia, according to the announcement.

In a pivotal phase 3 trial, sodium zirconium cyclosilicate significantly reduced blood serum potassium to normal levels within 48 hours, and that was sustained in 12 days of maintenance therapy. In another study, patients achieved the same reduction, and a higher proportion of patients maintained normal potassium levels for 28 days.

The CHMP recommendation will now go to the European Commission for possible adoption for EU-wide marketing, plus marketing in Iceland, Norway, and Liechtenstein.

AstraZeneca subsidiary ZS Pharma is developing sodium zirconium cyclosilicate, which is also under regulatory review in the US and Australia.

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