Bimekizumab Now Under Review in Europe for Axial Spondyloarthritis
Antibody-based therapy currently approved for certain types of psoriasis
The European Medicines Agency has agreed to review UCB’s applications seeking the approval of bimekizumab for adults with active axial spondyloarthritis (axSpA).
Axial spondyloarthritis is a type of inflammatory arthritis affecting the joints of the spine, chest, and pelvis. Ankylosing spondylitis (AS) is a severe type of axSpA, with hallmark symptoms including inflammation of the sacroiliac joints, where the base of the spine meets the pelvis.
A similar application was accepted for review for the treatment of adults with active psoriatic arthritis (PsA), which is primarily characterized by inflammation of the hand and feet joints in combination with psoriasis, a skin condition marked by patches of red, irritated skin.
These represent the first regulatory submissions for bimekizumab for these two conditions worldwide.
“These two regulatory applications in psoriatic arthritis and axial spondyloarthritis represent a significant milestone for bimekizumab as well as an important step towards expanding treatment options in the [European Union] for these debilitating conditions,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. at UCB, said in a company press release.
The review process will be conducted by the Committee for Medicinal Products for Human Use. The committee’s opinions are generally accepted by the European Commission, which makes final decisions on therapy approval for the 27-state European Union.
Bimekizumab is an antibody-based therapy designed to selectively block both IL-17A and IL-17F — two immune signaling proteins that drive inflammatory processes.
The therapy is currently approved for certain types of psoriasis in the European Union, Great Britain, Japan, Canada, and Australia. In the U.S., a regulatory decision for a similar indication was delayed until issues with facility inspections are resolved.
Bimekizumab, however, has not been approved for axSpA or PsA by any regulatory authority worldwide.
“If approved for these two new indications, bimekizumab would be the first new treatment option in psoriatic arthritis and axial spondyloarthritis to selectively target IL-17F, in addition to IL-17A,” Caeymaex said.
UCB’s application for axSpA was supported by data from two placebo-controlled Phase 3 trials: BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743). The ongoing BE MOBILE 1 study enrolled 240 adults with non-radiographic axSpA, another form of axSpA, while BE MOBILE 2 tested the therapy in 332 AS patients.
Both studies met their main and secondary goals, with bimekizumab being consistently superior to a placebo at lessening signs and symptoms of disease across both patient groups.
The application for psoriatic arthritis was based on findings from the completed BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) Phase 3 trials. Again, bimekizumab met primary and secondary goals in the trials, achieving clinically relevant reductions versus placebo in both joint and skin symptoms.
The therapy’s safety profile in all four Phase 3 studies was consistent with data seen in previous studies, with no new safety signals observed.
In psoriasis patients, the most frequently reported adverse reactions were upper respiratory tract infections (14.5%), mostly the common cold, and oral candidiasis or thrush (7.3%), a fungal infection affecting the mouth.
About the Author
