UCB had big plans for its psoriasis drug bimekizumab, but the FDA has decided the therapy’s approval ambitions are going nowhere until issues with facility inspections have been resolved.
The regulator previously delayed an approval decision in October, citing the inability to conduct on-site inspections of European facilities due to COVID-related travel restrictions. At the time, the FDA said action on the application would be deferred until the inspections can be completed.
Now, UCB has announced that a complete response letter has been received from the regulator stating the agency can’t consider the application in its current form, and “certain pre-approval inspection observations must be resolved before approval of the application.”
“We are cooperating with the FDA and are working to address these observations as expeditiously as possible,” the company said.
The rejection marks another frustrating obstacle for the Belgian biotech’s drug, which beat Johnson & Johnson’s Stelara in a phase 3 psoriasis trial in 2020. Over the past 10 months, bimekizumab has received marketing authorization for plaque psoriasis in the EU, Great Britain, Japan, Canada and Australia, the company pointed out.
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. Beyond psoriasis, the drug is also in trials for psoriatic arthritis, axial spondyloarthritis and a painful skin condition called hidradenitis suppurativa.
As a result of the FDA’s decision, UCB is reviewing financial guidance for 2022.