Mayor Kaladze questions safety of duchenne treatment drug, cites regulatory warning

Tbilisi Mayor Kakha Kaladze has raised concerns over the safety and effectiveness of a treatment for Duchenne muscular dystrophy, which families in Georgia are requesting the state to import.

Kaladze said that, according to his review of publicly available information, the manufacturer of the drug did not take full responsibility for its effectiveness and safety outcomes.

He referred to a warning issued by the US Food and Drug Administration, saying that the medication has been assigned a so-called “black box” warning, the safety alert used by the regulator.

The mayor said the issue should be considered beyond politics and framed it as a fundamental question of state responsibility in healthcare decision-making.

He argued that it would be difficult for the state to approve and fund a medicine for children when, in his view, the producer itself did not assume full responsibility for its outcomes.

Kaladze added that while he was not a medical specialist, the issue had prompted him to review available information due to its public importance and sensitivity.