🇪🇺 Duvyzat in European Union

EMA authorised Duvyzat on 6 June 2025

Marketing authorisation

EMA — authorised 6 June 2025

  • Application: EMEA/H/C/006079
  • Marketing authorisation holder: Italfarmaco S.p.A.
  • Local brand name: Duvyzat
  • Indication: Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
  • Pathway: conditional, orphan
  • Status: approved

On 6 June 2025, the European Medicines Agency (EMA) granted marketing authorisation for Duvyzat, a treatment for Duchenne muscular dystrophy (DMD). Duvyzat is indicated for ambulant patients aged 6 years and older, who are also receiving concomitant corticosteroid treatment. This approval was granted under the conditional and orphan drug pathways.

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Duvyzat in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Rare Disease approved in European Union

Frequently asked questions

Is Duvyzat approved in European Union?

Yes. EMA authorised it on 6 June 2025.

Who is the marketing authorisation holder for Duvyzat in European Union?

Italfarmaco S.p.A. holds the EU marketing authorisation.