No new safety signals emerged in more than a year

Im Juli wurde mit Givinostat (Duvyzat® 8,86 mg/ml Suspension zum Einnehmen, Italfarmaco) ein neuer Wirkstoff und eine neue Therapieoption bei Duchenne-...

La CE a accordé une autorisation de mise sur le marché conditionnelle pour givinostat dans le traitement de la dystrophie musculaire de Duchenne chez les patients ambulants âgés de 6 ans et plus, quelle que soit la mutation génétique sous-jacente, lorsqu'il est pris en association avec des corticostéroïdes.

The European Commission has granted the marketing authorization of Givinostat -Duvyzat-, a new oral treatment for Duchenne muscle dystrophy (DMD), a very serious, rare and progressive neuromuscular disorder, of genetic origin, which begins to manifest itself in childhood. This medicine, as tested so far, is capable of slow down the progression of the disease and preserve more time muscle function. Its approval is, therefore, it is an important milestone for patients, because, so far, there have been few approved and effective treatments to combat the disease.

Italfarmaco's Duvyzat scores conditional EU nod for DMD treatment  FirstWord Pharma

ITF Therapeutics presents significant patient-reported outcome data for DUVYZAT® (givinostat) in Duchenne muscular dystrophy at ISPOR 2025, enhancing quality of life insights.

L’Agence européenne du médicament vient de se prononcer favorablement à l’octroi d’une AMM en accès précoce pour Duvyzat, spécialité qui a permis d’améliorer la fonction motrice d’enfants atteints de dystrophie musculaire de Duchenne, après 18 mois de traitement.

Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular dystrophy (DMD).

ITF Therapeutics LLC shares important long-term data on DUVYZAT™ (givinostat) for Duchenne muscular dystrophy, highlighting safety and effectiveness at MDA conference.

ITF Therapeutics has opened a new headquarters in Concord, Massachusetts, focusing on rare diseases and community engagement. Aimed at fostering collaboration, it will serve as a hub for patient advocacy.

ITF Therapeutics LLC announces acceptance of seven abstracts for poster presentations at the 2025 MDA Conference showcasing DUVYZAT’s impact on DMD patients.