UCB Anticipates Delay for FDA Bimekizumab Decision
The anticipated BLA for bimekizumab to treat plaque psoriasis will likely be delayed beyond Q3 2023.
The anticipated Biologics License Application (BLA) for bimekizumab to treat plaque psoriasis will likely be delayed beyond Q3 2023, according to a statement from UCB. Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.
The company shared that they had received an Establishment Inspection Report (EIR) from the FDA following a pre-license inspection conducted at the its Belgium manufacturing facility in April 2023. The FDA is continuing its review of UCB’s application for bimekizumab,but they are no longer expected to make a decision by the end of September.
The FDA accepted UCB’s resubmitted BLA for bimekizumab in December 2022, with an anticipated 6-month review period. The FDA is continuing its review of the BLA for bimekizumab and has not communicated timelines required to take action on the application.
UCB will continue to collaborate with the FDA to advance and complete the full review of the bimekizumab BLA and its label. The next update for the bimekizumab BLA will be shared at the time of the FDA action.
Background on bimekizumab
In August 2021, bimekizumab received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) and Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments. In February 2022, March 2022 and April 2023, bimekizumab received marketing authorization in Canada, Australia and Mexico, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In July 2022, October 2022, January 2023 and May 2023 bimekizumab was approved in Saudi Arabia7, Switzerland, the United Arab Emirates and Kuwait, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
In June 2023, bimekizumab was first approved in countries of the EU/EEA, alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. In June 2023, bimekizumab was first approved in countries of the EU/EEA, for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.