EUNew treatments and approvals
European Commission grants conditional approval to oral givinostat for DMD
A decision by a medicines regulator (FDA, European Commission, etc.). The regulator has reviewed the clinical studies behind the drug. For accelerated or conditional approvals, the lasting benefit is still being confirmed.
The European Commission has granted conditional marketing authorization to givinostat for patients with DMD. The authorization covers ambulatory (able to walk) patients aged 6 years and older. The drug is used together with corticosteroids. It can be used regardless of the type of gene mutation. The approval is based on the results of the phase 3 EPIDYS study. It is valid in EU countries as well as Iceland, Liechtenstein and Norway.
What does it mean for patients and families?
A new oral treatment option has become available in Europe. It does not depend on the mutation type. Availability in Türkiye depends on TİTCK (Turkish Medicines and Medical Devices Agency) and SGK (Social Security Institution) processes.
Source
GlobeNewswire (Italfarmaco) · source page
The source page was opened and read on October 7, 2026. Summary prepared by the Doktorclub editorial team and translated from Turkish; it has not yet been reviewed by a physician (a scientific board is being set up).
This page is translated from the Turkish original.
Related disease: Duchenne muscular dystrophy (DMD)
This page reports a development; it is not a treatment recommendation. Your doctor decides whether a treatment is right for you.