FDA CRL - UGB, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to UGB, Inc. for its Biologics License Application (BLA) 761151 for UCB4940 (CDP4940), submitted under section 351(a) of the Public Health Service Act. The FDA determined that the application cannot be approved in its current form due to product quality concerns and deficiencies observed during a recent inspection of the UCB Pharma SA manufacturing facility. Satisfactory resolution of these manufacturing deficiencies is a prerequisite for approval. Additionally, UGB, Inc. is required to resubmit the proposed proprietary name, Bimzelx, and provide a comprehensive safety update as described in 21 CFR 314.50(d)(5)(vi)(b). This update must include detailed changes in the safety profile, presentation of new and combined clinical safety data, retabulated trial discontinuations, case reports and narrative summaries for deaths and serious adverse events, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. UGB, Inc. has one year to resubmit a complete response addressing all identified deficiencies or take other available actions, with an option to request a meeting to discuss the necessary steps.