FDA issues CRL for AZ’s hyperkalaemia drug

AstraZeneca has received a complete response letter from the US Food and Drug Administration regarding the new drug application for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.

AstraZenecasaid sodium zirconium cyclosilicate was being developed for the treatment of hyperkalaemia by its wholly-owned subsidiary ZS Pharma.

Hyperkalaemia is characterised by high potassium levels in the blood serum.

AstraZeneca said the CRL followed an inspection by the FDA of the ZS-9 manufacturing facility.

It said the CRL did not require the generation of any new clinical data.

A statement said: “AstraZeneca ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible.”

AstraZeneca said it remained dedicated to developing and commercialising sodium zirconium cyclosilicate for patients with hyperkalaemia, and was confident in the profile of this potential medicine.

It said that as announced on 24 February 2017, sodium zirconium cyclosilicate received a positive opinion by the Committee for Medicinal Products for Human Use in the European Union and any potential implications for ongoing regulatory submissions were being assessed.

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