Georgian Health Minister: Georgia to become among first countries to introduce Givinostat therapy for Duchenne muscular dystrophy

Georgian Health Minister Mikheil Sarjveladze announced on Friday that the government has signed a contract to procure Givinostat, a treatment for Duchenne muscular dystrophy (DMD), describing the move as a major milestone that will place Georgia among the first countries to make the therapy available.

In his remarks, Sarjveladze noted that the United Kingdom’s regulator approved Givinostat for use at the end of May, following its earlier authorisation by the European regulatory authority, while clinical studies on the treatment remain ongoing.

“This is one of the medicines that, from the very outset - when public interest first emerged and the issue entered broader discussion - we identified as among the most promising treatment options. We have followed its development with particular attention throughout the process. For example, on 28 May, the UK regulator authorised the use of Givinostat, following approval by the European regulatory agency, although clinical studies were still ongoing”, he said.

He noted that international assessments of the medicine have differed, explaining that French authorities issued a negative decision based on cost-effectiveness concerns, while Denmark decided against introducing the treatment in July, citing what it considered insufficient evidence.

“Developments related to Duchenne muscular dystrophy are progressing very rapidly, with numerous changes taking place, and all stakeholders are monitoring these processes with particular attention. The May decision was one of the most significant milestones. Shortly before that, France issued a negative decision on Givinostat, citing concerns related to its cost-benefit ratio. More recently, in July, Denmark decided not to introduce the medicine, citing a lack of sufficient evidence”, Sarjveladze noted.

“This is a very important process that requires particular caution, as we are dealing with an expensive medicine that is still relatively new and not yet fully established in scientific practice. Given these circumstances, the need for a careful approach is entirely understandable”, he continued.

The Minister added that Georgia has maintained close cooperation with its Italian counterparts throughout the process and will continue working with them as the implementation of the treatment programme moves forward.

“I would like to express my sincere gratitude to the Italian side, with whom we have been engaged in negotiations throughout this period and with whom we will continue our cooperation. This has been a very positive and constructive partnership. Among other things, we are discussing with our Italian counterparts that, as new developments arise during the implementation process, we will naturally need to maintain close cooperation”, he said.

Sarjveladze further emphasised that preparations would begin in August, including the development of treatment protocols, clinical infrastructure, monitoring systems, and other mechanisms required for the safe introduction of the medicine.

“Very soon, already in August, we will have the opportunity to begin joint work on implementing this process. This includes preparing the necessary protocols and guidelines, establishing the appropriate clinical infrastructure, setting up monitoring systems, and introducing all the instruments required for the safe use of the medicine. I am truly pleased that Georgia is among the first countries to take this step and that it can serve as an example for many other countries”, the Minister concluded.