UCB Anticipates Delay to FDA Bimekizumab Decision

The anticipated Biologics License Application (BLA) for bimekizumab to treat plaque psoriasis will likely be delayed beyond Q3 2023, according to a statement from global biopharmaceutical company UCB on Tuesday.¹

UCB shared in the statement that they had received an Establishment Inspection Report (EIR) from the FDA following a pre-license inspection conducted at the company’s Belgium manufacturing facility in April this year; while the agency is continuing its review of UCB’s application for bimekizumab, they are no longer expected to take action on the BLA by the end of September.

The FDA had accepted UCB’s resubmitted BLA for bimekizumab as a potential treatment of plaque psoriasis in adult patients in December 2022, with an anticipated 6-month review period.² The company then reported in June 2023 that the application would remain under review with the FDA through the following quarter.³ UCB reiterated its intent to continue seeking BLA approval for bimekizumab through the FDA, though without information as to when such a decision will be made.

“UCB continues to collaborate with the FDA to advance and complete the full review of the bimekizumab BLA and its label,” the company stated Tuesday. “The next update for the bimekizumab BLA will be shared at the time of the FDA action.”¹

An interleukin 17A and 17F (IL-17A; IL-17F) inhibitor, bimekizumab has been previously touted by dermatologists as a promising biologic in development to treat immune-mediated skin diseases. April W. Armstrong, MD, MPH, professor of dermatology and associate dean of clinical research at USC Keck School of Medicine, previously told HCPLive the agent’s specific mechanism of action has been translated into “this exceptional level of clinical response that we see.”⁴

“The number of patients that are clear by bimekizumab, for example, by 4 months of time is higher than probably anything that we've seen thus far,” Armstrong said.

Long-term data from the phase 3 BE VIVID, BE READY and BE SURE trials—pooled for analysis and presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting—showed more than 4 in every 5 treated patients who achieved psoriasis skin clearance at week 16 maintained it through 96 weeks with bimekizumab.⁵

The data additionally showed improved clinical responses among patients who switched from secukinumab to bimekizumab after 48 weeks.

Globally, bimekizumab holds marketing approvals for psoriatic diseases beyond psoriasis including psoriatic arthritis, non-radiographic axial spondyloarthritis, active ankylosing spondylitis, and psoriatic erythroderma.

References

1. ^{UCB. UCB Provides Update on U.S. Regulatory Review of Bimekizumab. Press release. Last updated September 19, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Provides-Update-on-US-Regulatory-Review-of-Bimekizumab}
2. ^{UCB. UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab. Press release. Last updated December 23, 2022. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-FDA-Acceptance-of-BLA-Resubmission-for-Bimekizumab}
3. ^{UCB. UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab. Press release. Last updated June 26, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Provides-Update-on-US-FDA-Review-of-the-Biologics-License-Application-for-Bimekizumab}
4. ^{Smith T. April W. Armstrong, MD, MPH: Deucravacitinib, Bimekizumab, and Upadacitinib for Psoriasis. HCPLive. Published January 11, 2023. https://www.hcplive.com/view/april-armstrong-md-deucravacitinib-bimekizumab-upadacitinib-for-psoriasis}
5. ^{Butera A. Bimekizumab Provides Long-Term Psoriasis Skin Clearance. HCPLive. Published March 28, 2022. https://www.hcplive.com/view/bimekizumab-provides-long-term-psoriasis-skin-clearance}