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Manufacturing issues prevent FDA approval of hyperkalemia agent

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AstraZeneca announced it received a complete response letter from the FDA for its application for approval of sodium zirconium cyclosilicate following an inspection of its manufacturing facility.

The letter stated generation of new data is not required, according to a press release from the company.

Sodium zirconium cyclosilicate (ZS-9; AstraZeneca/ZS Pharma) is a novel treatment for hyperkalemia that has potential for use in patients with HF who need to take renin-angiotensin-aldosterone system inhibitors but cannot because of their association with hyperkalemia.

AstraZeneca had previously received a letter from the FDA saying the drug could not be approved due to results from a manufacturing inspection.

According to the release, Asztra Zeneca and ZS Pharma, the company which developed the agent and that was acquired by AstraZeneca in 2015, “are committed to working with the FDA to resolve the remaining matters under review as soon as possible.”

The company wrote in the release that it is “confident in the profile of this potential medicine.”

Sodium zirconium cyclosilicate received a positive opinion by the Committee for Medicinal Products for Human Use in the European Union in February.