AstraZeneca’s subsidiary ZS Pharma has been developing an oral powder as a treatment for high potassium levels in the blood serum, called hyperkalaemia, for which it got a Complete Response Letter (CRL) from the Food and Drug Administration (FDA).
AstraZeneca announced Friday FDA’s issuing of the CRL, after inspecting the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data.
“AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible,” the parent company said in a statement, without saying what the remaining matters to be resolved are.
AstraZeneca said it will continue with the development and commercialisation of the sodium zirconium cyclosilicate, and 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. “Any potential implications for ongoing regulatory submissions are being assessed,” the company said.