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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.