FDA Delays UCB’s Bimekizumab Approval

lkeskinen/AdobeStock

UCB announced today that it has received an Establishment Inspection Report (EIR) from the FDA after the pre-license inspection conducted at its Belgium manufacturing facility in April 2023, which includes the production of bimekizumab for the treatment of adult patients with moderate to severe plaque psoriasis. The FDA has stated that the inspection is “successfully closed.”¹

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 FDA issued a complete response letter to UCB regarding it BLA for bimekizumab and stated that “it cannot approve the BLA in its current form.” At the time, pre-approval inspection observations were made during the approval process that needed to be resolved before moving forward.²

In early 2021, the FDA gave UCB a Prescription Drug User Fee Act date of October 15, 2021,³ but then delayed the approval due to needing an on-site facility inspection, and the COVID-19 pandemic restricted travel to and inspections of the Belgium facility.⁴

References

1. UCB provides update on US regulatory review of bimekizumab. UCB. News release. September 20, 2023. Accessed September 20, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Provides-Update-on-US-Regulatory-Review-of-Bimekizumab

2. Update on US FDA review of biologics license application (BLA) for bimekizumab. UCB. News release. May 13, 2023. Accessed September 20, 2023. https://www.ucb.com/stories-media/Press-Releases/article/Update-on-US-FDA-Review-of-Biologics-License-Application-BLA-for-bimekizumab-0

3. UCB announces PDUFA date for bimekizumab. April 28, 2021. Accessed September 20, 2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-pdufa-date-bimekizumab

4. FDA misses PDUFA date for bimekizumab. Formulary Watch. News release. October 19, 2021. Accessed September 20, 2023. https://www.formularywatch.com/view/fda-misses-pdufa-date-for-bimekizumab