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FDA rejects hyperkalemia treatment due to manufacturing issue
AstraZeneca announced that it received a complete response letter from the FDA indicating that sodium zirconium cyclosilicate will not be approved at this time due to results from a manufacturing inspection.
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.
The letter from the agency “refers to observations arising from a preapproval manufacturing inspection,” according to a press release from AstraZeneca. “The FDA also acknowledged receipt of recently submitted data which it has yet to review. The [letter] does not require the generation of new clinical data.”
According to the release, AstraZeneca and ZS Pharma, the company which developed the agent and that was acquired by AstraZeneca in December, “are evaluating the content of the [letter] and will work closely with the FDA to determine the appropriate next steps for the [new drug application].”
The company wrote in the release that it “remains committed” to the development of sodium zirconium cyclosilicate and is continuing to work with health agencies in the European Union and Australia, where the agent also is being considered for approval.