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Astellas’ Zolbetuximab Approval Timeline Unclear After Manufacturing Issues Prompt CRL

 
• By Lisa Takagi

After a US FDA site inspection raised questions about the contract manufacturer of the potential first-in-class Claudin 18.2 inhibitor that could not be answered by the original January PDUFA date, Astellas will need to refile the application, but has not committed to when that might be.

Supposed-to-be the global first approval for zolbetuximab was stopped due to manufacturing issues.
potential global-first approval of zolbetuximab hits road bump • Source: Shutterstock

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 presented in the clinical data submitted in the Biologics License Application, filed last July with a priority review for the treatment of CLDN18

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