FDA issues CRL on AstraZeneca hyperkalemia drug candidate

17 March 2017

AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).

Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalemia by ZS Pharma, now a wholly-owned subsidiary of AstraZeneca following its $2.7 billion acquisition in late 2015. Hyperkalemia is characterized by high potassium levels in the blood serum.

The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data. AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible, the Anglo-Swedish pharma major said.

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