FDA accepts review of AstraZeneca drug for hyperkalaemia

18th Oct 2016 07:21

(ShareCast News) - 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.