Source: European Parliament
Question for written answer E-002800/2025
to the Commission
Rule 144
Michael McNamara (Renew)
Givinostat, sold under the brand name Duvyzat, is a medication used to treat Duchenne muscular dystrophy (DMD) in patients aged six and older. It is not currently authorised in the EU.
On 25 April 2025, the European Medicine Agency’s Committee for Human Medicinal Products (CHMP) recommended granting a conditional marketing authorisation in the EU for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are able to walk.
As per that statement, the CHMP opinion has been sent to the Commission for consideration.
However, the EMA has so far not granted marketing authorisation for the use of givinostat in any cases.
- 1.What steps have been taken in relation to authorisation of this drug so that families across the EU can avail of it?
- 2.Will the Commission grant marketing authorisation for givinostat?
Submitted: 9.7.2025