27 May 2016 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new drug application for sodium zirconium cyclosilicate (ZS-9), 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 complete response letter (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 will work closely with the FDA to determine the appropriate next steps for the new drug application.

AstraZeneca remains committed to the development of sodium zirconium cyclosilicate as a treatment option for patients with hyperkalaemia. Interactions are ongoing with other health authorities in the European Union and Australia, where sodium zirconium cyclosilicate is currently under separate regulatory review.

For more details, go to: https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca-receives-complete-response-letter-from-us-fda-for-sodium-zirconium-cyclosilicate-zs-9-for-oral-suspension-for-treatment-of-hyperkalaemia-27052016.html