UCB's Bimzelx wins expanded EU approval as US decision looms

08 Jun 2023
firstwordpharma.com
Drug ApprovalPhase 3Clinical ResultAccelerated Approval
The European Commission expanded approval of UCB's Bimzelx (bimekizumab) to include the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA), including non-radiographic (nr-axSpA) and ankylosing spondylitis (AS). The company noted that the authorisation marks the first for the dual IL-17A and IL-17F inhibitorIL-17F inhibitor in the two indications.
Bimzelx was initially cleared in Europe in 2021 for the treatment of moderate-to-severe plaque psoriasis. The product, which is also available in the UK, Canada and Japan, generated sales of €35 million ($38 million) last year, up from €4 million ($4.3 million) in the prior 12-month period.
According to UCB, Bimzelx is approved alone or in combination with methotrexate for the treatment of adults with PsA who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Meanwhile, the therapy is indicated for adults with active nr-axSpA who show objective signs of inflammation and who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs. It is also indicated for adults with active AS who have responded inadequately or are intolerant to conventional therapy.
Results supporting approval in PsA come from the Phase III BE OPTIMAL and BE COMPLETE studies, in which Bimzelx met the primary endpoint of ACR50 response at week 16 versus placebo. Meanwhile, clearance in axSpA is based on findings from the late-stage BE MOBILE 1 and BE MOBILE 2 trials, with UCB's therapy achieving the primary endpoint of Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16 compared to placebo.
US decision pending
UCB is also seeking approval of Bimzelx in the US, but has so far been unsuccessful, with the FDA issuing a complete response letter last year in relation to a filing in moderate-to-severe plaque psoriasis. The agency cited a number of deficiencies at a Belgian manufacturing plant, although the company was quick to resubmit its application, which has a target review date in the second quarter of 2023.
However, last month, the FDA published a notice disclosing a Form 483 that had been sent to UCB outlining three issues identified at a follow-up visit to the manufacturing facility. Although Jefferies analyst Brian Balchin suggested that the deficiencies appear "less challenging" than those that resulted in the initial rejection, he said another complete response letter could further delay approval until the second quarter of 2024.
For related analysis, read Spotlight On: UCB hoping to avoid painful déjà vu on Bimzelx.
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