After FDA rejection, AstraZeneca re-submits application for hyperkalemia drug

Five months after the FDA rejected the approval of sodium zirconium cyclosilicate (ZS-9), the agency accepted a resubmission of the new drug application, according to an AstraZeneca news release.

ZS Pharma, a wholly owned subsidiary of AstraZeneca, manufactures ZS-9. The medication, which is indicated to treat patients with hyperkalemia, is not approved in any country.

Hyperkalemia often occurs in patients with chronic heart failure and/or advanced kidney disease. The condition, which is defined as potassium levels greater than 5.0 mEq/L in the blood serum, could lead to cardiac arrest and death.

In May, after the FDA declined to approve ZS-9, AstraZeneca acknowledged it had received a complete response letter from the FDA. The company said the letter detailed issues with a pre-approval manufacturing inspection. ZS Pharma did not have to conduct a new trial before resubmitting the application.

AstraZeneca acquired ZS Pharma in November 2015 in an all-cash transaction for $2.7 billion. At the time, AstraZeneca said it expected sales of ZS-9 to eventually exceed $1 billion per year.

AstraZeneca said ZS-9 has been evaluated in more than 1,600 patients in four clinical trials, including an ongoing 12-month open label study of patients with hyperkalemia.