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FDA Sets PDUFA Date for Bimekizumab

Dermatology TimesDermatology Times, June 2021 (Vol. 42, No. 6)
Volume 42
Issue 6

The FDA has set a Prescription Drug User Fee Act (PDUFA) date for bimekizumab (UCB) for the treatment of psoriasis.

UCB announces the FDA has set the Prescription Drug User Fee Act (PDUFA) date for UCB’s Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The FDA plans on making a decision on approval for the drug on October 15, 2021, according to a press release from the company.1

Bimekizumab is an investigational humanized monoclonal immunoglobulin (Ig)G1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, both of which are considered to be two key cytokines driving inflammatory processes.

Bimekizumab is supported by data from multiple phase 3 studies (BE READY, BE SURE, BE VIVID) investigating the safety and efficacy of the biologic in adult moderate to severe chronic plaque psoriasis patients. 

In the results, bimekizumab showed positive responses according to a press release on September 22, 2020. Primary endpoints were met across all phase 3 studies, with bimekizumab-treated patients demonstrating superior skin clearance at Week 16 versus patients treated with adalimumab (Humira, AbbVie) and placebo as measured by the Psoriasis Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear (0) or almost clear (1).2

Additionally, all phase 3 studies met their secondary endpoints. In two of the studies, bimekizumab-treated patients demonstrated total skin clearance at Week 16 (PASI 100), verifying superiority over ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) and adalimumab. Bimekizumab was superior to ustekinumab, adalimumab and placebo in achieving rapid response (PASI 75 at Week 4) and clinical responses were sustained up to one year across all studies. Also, the studies’ safety profiles were consistent with previous clinical studies.

If approved, UCB will release bimekizumab to patients starting in the second half of 2021.


1. UCB. (2021, April 28th). UCB Announces PDUFA Date for Bimekizumab. Retrieved April 28, 2021, from https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-pdufa-date-bimekizumab

2. UCB. (2020, September 22). UCB Achieves Important Regulatory Milestone for Bimekizumab. Retrieved September 22, 2020, from https://www.prnewswire.com/news-releases/ucb-achieves-important-regulatory-milestone-for-bimekizumab-301135154.htm

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