FDA rejects AZ's ZS-9

AstraZeneca plc (LSE:AZN; NYSE:AZN) received a complete response letter (CRL) from FDA for hyperkalemia treatment ZS-9 sodium zirconium cyclosilicate. AZ gained the candidate via its $2.7 billion acquisition of ZS Pharma Inc. in 4Q15 (see BioCentury Extra, Nov. 6, 2015).

AZ said the CRL cited "observations arising from a pre-approval manufacturing inspection." It said FDA has "acknowledged receipt of recently-submitted data which it has yet to review," and noted that the CRL does not require additional clinical data. AZ spokesperson Michele Meixell told BioCentury that FDA identified undisclosed issues during a March inspection. ...