Astellas Pharma, Inc. has received a Complete Response Letter (CRL) from the US Food And Drug Administration for its potential first-in-class Claudin 18.2 inhibitor zolbetuximab, due to “the unresolved deficiencies following its [FDA] pre-license inspection of a third-party manufacturing facility” which could not be answered by the original Prescription Drug User Fee Act (PDUFA) action date of 12 January.
The Japanese firm stressed the US regulator had raised no concerns over the safety or efficacy of the drug as...
