FDA accepts review of AstraZeneca drug for hyperkalaemia

The US Food and Drug Administration has accepted a complete re-submission of a new drug application for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia by AstraZeneca’s subsidiary ZS Pharma.

Hyperkalaemia – high potassium levels in the blood serum – commonly occurs in patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death.

AstraZeneca said the FDA has indicated this is a complete class 2 response.

Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.