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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of AstraZeneca’s ZS-9 (sodium zirconium cyclosilicate) to treat hyperkalaemia.
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An approval from EMA would make the drug available for the treatment of hyperkalaemia in all the 28 member states of the European Union along with Iceland, Liechtenstein and Norway.
In hyperkalaemia, patients have high levels of potassium in the blood serum due to cardiovascular, renal and metabolic diseases.
It is a serious condition that can affect 23-47% of patients having chronic kidney disease with or without chronic heart failure. If it is not treated on time, hyperkalaemia can potentially lead to cardiac arrest and death.
ZS-9, an insoluble, non-absorbed zirconium silicate compound is developed by AstraZeneca subsidiary ZS Pharma . It is claimed to treat hyperkalaemia by selectively removing potassium.
The CHMP's recommendation is based on the data of four trials, three double-blind placebo-controlled and a current 1-year open-label trial in adult hyperkalaemia patients.
A crucial phase 3 study demonstrated that ZS-9 that was given as an oral suspension considerably decreased potassium in the blood serum to normal levels (normokalaemia) inside 48 hours for a span of 12 days of maintenance treatment.
In an additional study, the same pattern was observed with a higher portion of patients showing normokalaemia for up to 28 days on ZS-9 treatment in comparison to placebo.
Both acute and chronic hyperkalaemia patients had their blood serum potassium levels significantly decreased rapidly and effectively with ZS-9 in the trials as per AstraZeneca.
ZS-9 is also under regulatory review in Australia and the US, with decisions anticipated to come in the first half of the year.