Ucb S A - UCBJY STOCK NEWS

The US FDA has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. BIMZELX is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

UCB receives FDA approval for ZILBRYSQ®, a once-daily subcutaneous treatment for generalized myasthenia gravis (gMG) in adult patients

UCB to present data on bimekizumab in hidradenitis suppurativa at symposium

UCB announces positive results from Phase 3 bimekizumab studies in hidradenitis suppurativa

The Child Neurology Society Meeting will showcase UCB's research on Dravet syndrome. A retrospective analysis showed that fenfluramine reduced healthcare utilization by 77% in individuals with Dravet syndrome, along with reductions in ER visits, outpatient visits, neurology visits, and inpatient hospitalizations. The survey highlighted challenges in early diagnosis and the importance of patient advocacy groups and online resources. These advancements in understanding and managing Dravet syndrome are positive for UCB.

UCB's RYSTIGGO® (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients. The approval is based on a Phase 3 study that showed significant improvements in gMG-specific outcomes. RYSTIGGO® is the only FDA-approved treatment for both anti-AChR and anti-MuSK antibody-positive gMG.

UCB announced its participation in the 75th American Academy of Neurology Annual Meeting from April 22-27, 2023, showcasing its neurology portfolio. The company will present 12 abstracts, including two oral presentations on treatments for generalized myasthenia gravis (gMG) and epilepsy syndromes like Lennox-Gastaut syndrome (LGS). Highlights include findings from the MycarinG and RAISE studies, detailing efficacy and safety of investigational treatments rozanolixizumab and zilucoplan for adults with gMG. UCB will also feature analyses on BRIVIACT and FINTEPLA, focusing on their impacts on seizure frequency and cognitive functions. Key sessions include a panel on seizure emergencies and cluster identification in adults, emphasizing UCB's commitment to improving patient outcomes in neurology.

UCB announced that the U.S. Drug Enforcement Administration has descheduled FINTEPLA oral solution, removing it from controlled substances classification effective immediately. This allows prescribers to issue prescriptions for a full year instead of six months, enhancing patient access to treatment for Dravet syndrome and Lennox-Gastaut syndrome. The company will update relevant state compendia accordingly. FINTEPLA, FDA-approved for patients aged 2 and older, is developed by UCB following their acquisition of Zogenix, Inc. in March 2022. The descheduling is expected to ease prescription processes for patients and caregivers, potentially increasing the drug’s usage for those in need.