UCB announced that it will be presenting results from across its portfolio in generalized myasthenia gravis (gMG) at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) annual meeting and the Myasthenia Gravis Association of America Scientific Session taking place November 1-4, 2023. Additional results from the MycarinG and RAISE studies,1,2 and their open-label extension studies will be presented, investigating UCB's rozanolixizumab-noli, a subcutaneously (SC)-injected monoclonal antibody targeting the neonatal Fc receptor (FcRn)3,4 and zilucoplan, a self-administered, subcutaneously injected peptide inhibitor of complement component 5 (C5 inhibitor) in adults with gMG.5 These two Phase 3 trials supported U.S., EU, and Japanese regulatory filings of both rozanolixizumab-noli and zilucoplan. ZILBRYSQ was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive,6 following FDA approval of RYSTIGGO for treatment of gMG in adult patients who are anti-AChR antibody-positive or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive earlier this year.7 ZILBRYSQ and RYSTIGGO were also recently approved in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW)8. Both medicines are also under review by the European Medicines Agency (EMA) for the treatment of adults with gMG, with zilucoplan having recently received a positive CHMP opinion.

Responses to these submissions are expected before the end of the year. These data further inform UCB's innovative approach to evolving science into meaningful solutions that help improve outcomes and help address unmet needs of people living with gMG. As part of ongoing work to reveal better understanding of the patient and societal burden of gMG, UCB will also present posters on real-world data providing insights into the impact of social determinants of health on treatment of people with MG and the increase in risk of gMG exacerbation and healthcare resource utilization (HCRU) associated with higher MG-ADL scores.

Further demonstrating their commitment to finding solutions for unmet needs within the gMG community, UCB will also present study designs for Phase 2/3 studies to assess zilucoplan and rozanolixizumab-noli in pediatric patients with gMG. In total, fourteen abstracts will be presented, including three as oral presentations. In addition to contributing to the AANEM and MGFA scientific programme, UCB will be hosting a sponsored therapeutic update session entitled "New Horizons: Navigating a New Treatment Landscape for gMG" onsite at the congress.