London : AstraZeneca said that U.S. regulators had rejected the British company’s new drug for high potassium levels, in the latest setback to the product.
AstraZeneca said it had been issued with a complete response letter (CRL) from the U.S. Food and Drug Administration for its ZS-9 drug. Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval.
The rejection is the second time the FDA has failed to approve the drug which Astra acquired when it bought ZS Pharma for $2.7 billion in 2015.
“The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility,” Astra said. “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.”
ZS-9 treats hyperkalaemia, or high potassium levels, which is typically associated with chronic kidney disease and chronic heart failure.