Italfarmaco issues statement regarding Georgian Health Ministry’s decision to procure Givinostat

Italian pharmaceutical company Italfarmaco has announced a managed entry agreement with the Georgian Ministry of Health for the supply of Givinostat, a medication used to treat Duchenne muscular dystrophy.

According to Italfarmaco, following European Commission (EC) approval in June 2025, Givinostat will be made available in Georgia for ambulant patients aged six and over, to be taken in combination with corticosteroids.

The company noted in its statement that the agreement is designed to support access to the new innovative pharmaceutical product for eligible patients with Duchenne muscular dystrophy in Georgia, reflecting the Ministry of Health’s ongoing commitment to provide treatments for rare diseases.

“Italfarmaco expressed its gratitude to the Georgian Ministry of Health for identifying practical solutions for eligible patients, confirming it will continue to support the Duchenne community through this partnership.
Furthermore, the pharmaceutical company explained that it will continue working with the Ministry to support launch readiness and enhance multidisciplinary care for Duchenne muscular dystrophy patients across the country.

As Francesco Di Marco, PhD, CEO of Italfarmaco Group, stated: “This milestone reflects the Georgian Ministry of Health’s strong commitment to improving care for people living with rare diseases and the constructive collaboration between healthcare stakeholders, the Duchenne community and Italfarmaco throughout this process,” the company said in a statement.

As noted in the company’s release, European Commission approval is based on the results of the EPIDYS Phase 3 multicentre, randomised, double-blind, placebo-controlled trial (NCT02851797). In the EPIDYS study, a total of 179 ambulant boys six years of age or older received either Givinostat twice daily or placebo, in addition to corticosteroid treatment.

“The EPIDYS study met its primary endpoint, demonstrating a statistically significant difference in time to complete the four-stair climb assessment. Givinostat also showed favourable results on key secondary endpoints including North Star Ambulatory Assessment (NSAA) and fat infiltration evaluation by magnetic resonance imaging. Specifically, givinostat treatment was associated with 40% less decline in cumulative loss of NSAA items, indicating givinostat’s potential to delay disease progression in affected individuals. Results from this study were published in The Lancet Neurology in March 2024,” Italfarmaco stated in its release.

For context, founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company operating in more than 90 countries across therapeutic areas including immuno-oncology, gynaecology, neurology, cardiovascular disease, and rare diseases.