
FDA Delays UCB’s Bimekizumab Approval
FDA action is no longer expected in Q3 of 2023.
This article was originally
The FDA will continue to review UCB’s bimekizumab Biologics License Application (BLA) but has not provided any further details on a new timeline to take action. UCB no longer anticipates FDA action in Q3 of 2023.
As UCB waits for further details on bimekizumab’s approval, it will continue to work with the FDA to complete the full review of bimekizumab’s BLA and its label. According to UCB, “The next update for the bimekizumab BLA will be shared at the time of the FDA action. UCB’s previously communicated 2023 financial guidance range remains unchanged.”
In March of 2022, the
In early 2021, the FDA gave UCB a Prescription Drug User Fee Act date of
References
1. UCB provides update on US regulatory review of bimekizumab. News release. UCB. September 20, 2023. Accessed September 20, 2023.
2. Update on US FDA review of biologics license application (BLA) for bimekizumab. News release. UCB. May 13, 2023. Accessed September 20, 2023.
3. UCB announces PDUFA date for bimekizumab. News release. UCB. April 28, 2021. Accessed September 20, 2023.
4. FDA misses PDUFA date for bimekizumab. Formulary Watch. October 19, 2021. Accessed September 20, 2023.
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