FDA accepts resubmitted filing for AstraZeneca's hyperkalaemia therapy ZS-9

The FDA accepted a resubmitted marketing application for AstraZeneca's ZS-9 (sodium zirconium cyclosilicate) as a treatment for hyperkalaemia, the company reported Tuesday. AstraZeneca indicated that discussions with health authorities in the EU and Australia are ongoing with decisions expected in the first half of 2017.

In May, the FDA issued a complete response letter regarding a filing for​ ZS-9, citing observations arising in a pre-approval manufacturing inspection (for related analysis, read ViewPoints: ZS-9 delay could be doubly painful for AstraZeneca). AstraZeneca said Tuesday that the regulator indicated that the resubmission is a complete class 2 response.

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AstraZeneca acquired rights to ZS-9 via its $2.7-billion takeover of ZS Pharma in 2015. The UK drugmaker has previously forecast global peak sales of more than $1 billion for the therapy.

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