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UCB SA UNSP/ADR (UCBJY) is a global biopharmaceutical company focused on developing innovative medicines for immune system and central nervous system diseases. Recent achievements include 48-week post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies for hidradenitis suppurativa patients, showing clinically meaningful improvements in skin pain and draining tunnels with BIMZELX treatment. The company is actively pursuing regulatory applications globally for the approval of BIMZELX.
UCB announced that Epilepsia published findings from an analysis on FINTEPLA® (fenfluramine) evaluating its effectiveness in reducing generalized tonic-clonic seizures (GTCS) and tonic-clonic seizures (TCS) among patients with developmental and epileptic encephalopathies (DEEs). The study, adhering to PRISMA-ScR guidelines, included 14 eligible studies out of 422, identifying 421 unique patients with conditions like Dravet syndrome and Lennox-Gastaut syndrome. Results showed a median reduction in seizure frequency from 47.2% to 100%, with 72% of patients achieving a ≥50% reduction, and 54% achieving a ≥75% reduction. The promising results align with previous FINTEPLA clinical trial data, indicating its potential in managing severe seizures in DEEs.
UCB presented results from three studies on CIMZIA® (certolizumab pegol) at the European Congress of Rheumatology (EULAR) 2024.
The CHERISH study indicated pregnant women with chronic immune-mediated diseases could maintain their dosing regimen of certolizumab pegol throughout pregnancy, showing stable blood plasma concentrations similar to non-pregnant women.
Another study found that rheumatoid factor (RF) antibodies bind to Fc-containing TNFis but not to certolizumab pegol, suggesting molecular insights for personalized rheumatoid arthritis (RA) treatments.
Additionally, the REALISTIC trial's post-hoc analysis revealed that high RF patients with RA responded similarly to certolizumab pegol over time, regardless of RF levels, even in TNFi inadequate responders.
These findings underscore the potential for more personalized treatment approaches in patients with high unmet needs.
UCB has unveiled two-year data from Phase 3 studies on BIMZELX (bimekizumab) for axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) at EULAR 2024. The data, from studies BE MOBILE 1, BE MOBILE 2, BE MOVING, BE OPTIMAL, and BE COMPLETE, showed that BIMZELX achieved sustained clinical and patient-reported outcomes. Over 90% of ankylosing spondylitis (AS) patients saw no spinal radiographic progression. In psoriatic arthritis, both biologic-naïve patients and those with prior inadequate responses to other treatments maintained minimal disease activity (MDA) for two years. However, BIMZELX is not yet approved in the U.S. for these indications.
Highlights include: 50% of axSpA patients achieved ≥40% improvement, 61% reached low disease activity, and 30% achieved inactive disease. In PsA, around 50% reached and sustained MDA. The drug also improved spinal pain, morning stiffness, and fatigue, with no new safety signals observed.
UCB has announced that The Lancet has published results from the Phase 3 BE HEARD I and II trials evaluating BIMZELX® (bimekizumab-bkzx) in treating moderate-to-severe hidradenitis suppurativa (HS). These trials are the first to assess an IL-17A and IL-17F inhibitor for HS. The positive results support global regulatory submissions for BIMZELX. In April 2024, the FDA accepted a review of the supplemental biologics license application for BIMZELX, and the European Commission granted marketing authorization for the treatment of HS in adults who haven't responded to conventional therapy. Other regulatory submissions are ongoing worldwide.
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