AstraZeneca Receives Complete Response Letter for Manufacturing Issues

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding AstraZeneca’s new drug application (NDA) for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly owned subsidiary of AstraZeneca.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and said that they will work closely with the FDA to determine the appropriate next steps for the NDA.

Sodium zirconium cyclosilicate is an insoluble, non-absorbed compound with a structure that was designed to preferentially trap potassium ions. The potassium selectivity of sodium zirconium cyclosilicate enables high in-vitro binding capacity for potassium ions even in the presence of other competing ions.

ZS Pharma was founded in 2008, became a public company in 2014 and,was acquired by AstraZeneca in December 2015.

Source: AstraZeneca

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