Written question - Authorisation of givinostat for the treatment of Duchenne muscular dystrophy - E-002800/2025

Published 9 hours ago• 1 minute read

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.

Submitted: 9.7.2025

Last updated: 14 July 2025

Origin:

europa

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Written question - Authorisation of givinostat for the treatment of Duchenne muscular dystrophy - E-002800/2025

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