You are here

FDA Rejects Hyperkalemia Drug ZS-9 for Second Time

Agency finds fault with manufacturing facility

The FDA has issued a complete response letter (CRL) regarding the new drug application for ZS-9 (sodium zirconium cyclosilicate, ZS Pharma/AstraZeneca), which is being developed for the treatment of patients with hyperkalemia.

CRLs typically outline concerns and conditions that must be addressed to gain FDA approval. The CRL for ZS-9 followed an inspection by the FDA of the drug’s manufacturing facility. The CRL does not require the generation of any new clinical data.

This is the second time the FDA has declined to approve ZS-9, which AstraZeneca acquired when it bought ZS Pharma in 2015.

ZS-9 is a powder for oral suspension. The active ingredient is a nonabsorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. Clinical trials have indicated that the compound is stable at room temperature and has a rapid onset of action, according to AstraZeneca. The FDA submission included data from double-blind, placebo-controlled trials and an 11-month open-label extension study in adults with hyperkalemia.

Hyperkalemia occurs in 23% to 47% of patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death. The mortality rate can be as high as 30% in patients with severe hyperkalemia if the disorder is not treated. Commonly used heart medications can also cause hyperkalemia.

Sources: AstraZeneca; March 17, 2017; and Reuters; March 17, 2017.

Recent Headlines

Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs