US regulators have accepted AstraZeneca unit ZS Pharma’s resubmission of ZS-9, a potassium-binding compound being developed for hyperkalaemia.
Hyperkalaemia commonly occurs in patients with chronic kidney disease or heart failure, and is characterised by high levels of potassium in the blood that can lead to cardiac arrest and death.
ZS-9 (sodium zirconium cyclosilicate) is an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions.
The drug was rejected by the US Food and Drug Administration last May, via a Complete Response Letter that reportedly highlighted certain manufacturing issues.
The medicine is yet to receive its first global approval; interactions with other health authorities in the European Union and Australia are ongoing, with decisions expected in the first half of 2017, the firm noted.
AstraZeneca picked up ownership of the drug via its acquisition of ZS Pharma for $2.7 billion in December last year.
