US CRL For Astellas's Zolbetuximab Over Manufacturing Issues

Revised Approval Timeline Unclear

10 Jan 2024

Astellas has received a US CRL for it's potential first-in-class drug zolbetuximab, after questions over a manufacturing line came up after an FDA site inspection and could not be answered by the original 12 January PDUFA date. The Japanese firm will refile the application after resolving the issues, but the likely revised timeline is not yet clear.

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...

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