Italfarmaco announced that additional data on givinostat for the treatment of Duchenne muscular dystrophy (DMD) are being presented at the 30th annual International Congress of the World Muscle Society (WMS) held October 7-11 in Vienna, Austria. Poster presentations highlight the long-term safety of givinostat in patients with DMD, explore efficacy by age in a post hoc analysis of the pivotal EPIDYS study, and provide a detailed characterisation of gastrointestinal adverse events observed in this Phase 3 study. << What is Duvyzat (Givinostat)? >>
These data from studies sponsored by Italfarmaco presented at the 2025 WMS Congress include:
651P Long-Term Safety of Givinostat in Patients With Duchenne Muscular Dystrophy: Results From an Open-Label Extension Study
The ongoing long-term study of givinostat in boys with DMD continues to provide insights into the safety and tolerability of the treatment, with results consistent with previous shorter-duration studies. Some patients have now been taking givinostat for more than 8 years in total, across several studies and extension phases.
684VP Efficacy of Givinostat by Age (6–7 and >7 Years): A Post Hoc Analysis of EPIDYS
Baseline assessments in the study provided key insights into physical function in boys with DMD across different age groups.
688VP Characterizing Gastrointestinal Adverse Events of Interest From a Phase 3 Study of Givinostat in Patients With Duchenne Muscular Dystrophy
The study continues to monitor gastrointestinal events in participants, with most reported events being mild to moderate in severity and resolving without requiring discontinuation of treatment. These findings provide important context for understanding the overall safety and tolerability of long-term therapy.
Read More: Clinical Trials for Duchenne (List of All Researches)
