FDA issues second CRL for AZ's hyperkalemia candidate

AstraZeneca plc (LSE:AZN; NYSE:AZN) said it received a second complete response letter from FDA for ZS-9, its candidate to treat hyperkalemia. The pharma said the CRL followed an FDA inspection of the ZS-9 manufacturing facility and does not require the company to generate additional data. Spokesperson Abigail Bozarth told BioCentury the company hopes to meet with FDA and resolve the situation quickly, but did not give a specific timeline.

In May 2016, AZ said it received its first CRL for ZS-9 due to "observations arising from a pre-approval manufacturing inspection.” It resubmitted its NDA for ZS-9 in October (see BioCentury Extra, Oct. 18, 2016)...