FDA accepts re-filing of NDA for ZS 9 (sodium zirconium cyclosilicate) to treat hyperkalaemia. -AstraZeneca
The FDA has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2 response.Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.
Comment: Hyperkalaemia (potassium levels more than 5.0 mEq/L in the blood serum) commonly occurs in patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death. Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia. Current therapeutic options are limited, leaving a high unmet medical need in these patients.
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