UCB expects FDA to delay decision on Bimekizumab

The expected biologics license application (BLA) for bimekizumab to treat plaque psoriasis may be delayed until after the third quarter of 2023, according to a statement from global biopharmaceutical company UCB on Tuesday.1

UCB said in a statement that it had received an establishment inspection report (EIR) from the FDA following a pre-licensing inspection at the company’s Belgian manufacturing facility in April this year; while the agency continues to review UCB’s bimekizumab application, it is expected that they No further action will be taken on the BLA until the end of September.

The FDA accepted UCB’s resubmission BLA for bimekizumab as a potential treatment for plaque psoriasis in adult patients in December 2022, with an expected review period of 6 months.2 The company subsequently reported in June 2023 that the application would remain under FDA review next quarter.3 UCB reiterated its intention to continue seeking BLA approval for bimekizumab through the FDA but did not disclose when such a decision would be made.

“UCB will continue to work with the FDA to advance and complete a comprehensive review of the bimekizumab BLA and its labeling,” the company said Tuesday. “The next update on the bimekizumab BLA will be shared when the FDA takes action.”1

Bimekizumab, an interleukin 17A and 17F (IL-17A; IL-17F) inhibitor, has previously been touted by dermatologists as a promising biologic for the treatment of immune-mediated skin diseases.April W. Armstrong, MD, MPH, professor of dermatology and associate dean for clinical research at the Keck School of Medicine of USC, previously stated HCP live The drug’s specific mechanism of action translated into “this exceptional level of clinical response that we saw.”4

“For example, the number of patients who are cured after four months of treatment with bimekizumab is probably greater than anything we’ve seen to date,” Armstrong said.

Long-term data from the Phase 3 BE VIVID, BE READY and BE SURE trials, which were pooled for analysis and presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting, show that more than 4 out of every 5 patients treated Psoriatic skin clearance was achieved at week 16 and maintained with bimekizumab through week 96.5

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

Globally, bimekizumab is approved for the treatment of psoriatic diseases other than psoriasis, including psoriatic arthritis, nonradiographic axial spondyloarthritis, active ankylosing spondylitis, and psoriasis Erythroderma.

refer to

  1. UCB. UCB provides the latest information on the U.S. regulatory review of Bimekizumab. Press release. Last updated on 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 resubmission of BLA for Bimekizumab. Press release. Last updated on 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 the latest information on the US FDA’s review of the biologics license application for Bimekizumab. Press release. Last updated on 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 in the treatment of psoriasis. HCPLive. Published on January 11, 2023. https://www.hcplive.com/view/april-armstrong-md-deucravacitinib-bimekizumab-upadacitinib-for-psoriasis
  5. Butera A. Bimekizumab provides long-term psoriatic skin clearance. HCPLive. Published March 28, 2022. https://www.hcplive.com/view/bimekizumab-provides-long-term-psoriasis-skin-clearance

Source link

Leave a Comment