The Biologics License Application (BLA) for bimekizumab, a humanized monoclonal immunoglobulin G1 (IgG1) antibody designed for the treatment of moderate to severe plaque psoriasis in adults, remains under review by the US Food and Drug Administration (FDA), global biopharmaceutical company UCB announced.
While UCB had initially anticipated action from the FDA in the second quarter of 2023, it now expects a decision will be made in the third quarter of 2023.
In a press release, the company noted that there are no open Information Requests from the FDA concerning the BLA for bimekizumab.
Bimekizumab has already obtained marketing authorizations in other countries not only for treating moderate to severe psoriasis but also for managing other conditions, such as generalized pustular psoriasis (GPP) and psoriatic erythroderma.
Read more about GPP therapies
“UCB is committed to ongoing collaboration with the FDA in order to bring bimekizumab to people in the US living with moderate to severe plaque psoriasis as soon as possible,” the company stated in its release.
Bimekizumab selectively inhibits both interleukin 17A and interleukin 17F—2 cytokines that play a central role in driving inflammatory processes. It is approved for the treatment of moderate to severe psoriasis in 10 regulatory authorities and across 39 countries worldwide.
In January 2022, bimekizumab was granted marketing authorization in Japan for the treatment of plaque psoriasis, GPP, and psoriatic erythroderma in patients who have an inadequate response to current treatment options.
In June 2023, countries of the European Union/European Economic Area granted approvals for 2 additional indications: the treatment of adults with active psoriatic arthritis, and the treatment of adults with active axial spondyloarthritis (axSpA), including nonradiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.
Reference
UCB provides update on U.S. FDA review of the Biologics License Application for bimekizumab. News release. UCB; June 26, 2023.
