Pharma major UCB has announced the European Commission approval for Bimzelx (bimekizumab), its humanized monoclonal IgG1 antibody. Bimzelx is said to exert simultaneous selective inhibition of interleukin 17A (IL-17A) and IL-17F, for adults with active psoriatic arthritis (PsA), and active non-radiographic axial spondyloarthritis (axSpA) who exhibit intolerance to non-steroidal anti-inflammatory drugs.
Representing a distinctive mechanism of action as a dual IL-17A/IL-17F inhibitor, Bimzelx is set to become a blockbuster for the treatment of these debilitating, chronic conditions, with a global sales forecast of $2.4 billion by 2029, according to GlobalData, a leading data and analytics company.
Mariam Shwea, Healthcare analyst at GlobalData, says, “The reported data revealed Bimzelx’ superior long-term disease control and significant clinical improvement in the signs and symptoms of PsA and axSpA patients when compared to the respective placebo groups.”
The efficacy of Bimzelx for PsA and axSpA was reinforced by the results of UCB’s randomized, double-blind, placebo-controlled Phase III Be Optimal (NCT03895203), Be Complete (NCT03896581), Be Mobile 1 (NCT03928704) and Be Mobile 2 (NCT03928743) clinical trial results.
The drug exhibited improved joint and skin symptoms in PsA patients across biologic-naïve and tumor necrosis factor (TNF) inhibitor-inadequate responder populations, and improvements in the signs, symptoms, and disease activity of axSpA patients across the full spectrum of the disease, meeting all primary and secondary endpoints throughout.
Shwea adds, “The positive results, its distinctive mechanism of action as a simultaneous selective IL-17A and IL-17F inhibitor, in addition to its demonstrated efficacy in clinical studies, position Bimzelx as an important treatment option in these therapeutic areas.”
The data presented by UCB at the EULAR European Congress of Rheumatology 2023 underlines the ability and potential of Bimzelx to attain high treatment targets and directly compete against formidable and well-entrenched biologic agents in the space, including AbbVie’s Humira (adalimumab) and Novartis’ Cosentyx (secukinumab).
Shwea concludes, “The extended European approval of UCB’s bimekizumab in these indications represents a significant milestone for the company in its commitment to address unmet patient needs and improve the quality of life for those affected by PsA and axSpA, building on the momentum created since its first approval in plaque psoriasis (PsO). The consistent high disease control achieved with Bimzelx as demonstrated by the clinical trial results, and its broadened European arena, highlight its potential to improve patient outcomes and raise standards of care of PsO, PsA and axSpA patients, among others.”
