MILAN, Italy, July 31, 2026
talfarmaco S.p.A. announced a managed entry agreement with the Georgian Ministry of Health to provide access to Duvyzat® (givinostat) for eligible patients with Duchenne muscular dystrophy (DMD). Under the agreement, based on the European Commission’s June 2025 approval, givinostat will be available in Georgia for ambulant patients aged six years and older receiving corticosteroid therapy. The initiative is designed to improve access to innovative treatments for rare diseases while supporting launch readiness and multidisciplinary care for patients living with DMD across the country.
Managed Entry Program Expands Access for Eligible DMD Patients
The agreement enables eligible patients in Georgia to receive givinostat under a managed access framework established in collaboration with the Georgian Ministry of Health. According to Italfarmaco, the initiative reflects the country’s continued commitment to improving care for individuals with rare diseases while facilitating access to innovative therapies before broader commercial availability. The company also plans to work closely with healthcare authorities to support implementation, physician education, and multidisciplinary patient management throughout the launch process.
Phase 3 EPIDYS Trial Demonstrated Clinical Benefit
The European Commission approval supporting the agreement was based on results from the Phase 3 EPIDYS trial, a multicenter, randomized, double-blind, placebo-controlled study involving 179 ambulant boys aged six years and older with Duchenne muscular dystrophy receiving corticosteroids. The study met its primary endpoint by demonstrating a statistically significant improvement in time to complete the four-stair climb assessment compared with placebo. Givinostat also produced favorable outcomes across key secondary endpoints, including the North Star Ambulatory Assessment (NSAA) and MRI-based evaluation of muscle fat infiltration. Treatment was associated with 40% less decline in cumulative NSAA item loss, suggesting the therapy may slow disease progression. Most adverse events observed during the study were reported as mild to moderate in severity.
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Long-Term Data Support Continued Disease Progression Delay
Interim findings from the ongoing EPIDYS open-label extension (OLE) study further support the long-term potential of givinostat. Patients receiving continuous treatment demonstrated a median age of loss of ambulation of 17.3 years, compared with 11.0 to 13.4 years reported in published natural history cohorts of corticosteroid-treated patients. Givinostat is an orally administered histone deacetylase (HDAC) inhibitor that targets excessive HDAC activity in DMD muscle tissue, helping restore biological pathways involved in muscle maintenance and repair regardless of the underlying dystrophin gene mutation. The therapy is currently approved in multiple regions, including the United States, European Union, United Arab Emirates, and the United Kingdom, with prescribing criteria varying by jurisdiction.
Source: Italfarmaco press release
