Duvyzat (Givinostat) has received regulatory approval in the US and UK and has completed its evaluation by the European Medicines Agency (EMA). EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are able to walk.
Duvyzat (givinostat), the first nonsteroidal therapy for Duchenne Muscular Dystrophy (DMD), received FDA approval in March 2024. Although this is good news for all patients and their families, many outside of the United States wondered when givinostat for DMD will be approved in their countries as well.
The European Medicines Agency (EMA) has suggested that Duvyzat (givinostat) be given a conditional marketing authorization in the EU to treat Duchenne muscular dystrophy (DMD) in individuals who can walk starting at age six. Duvyzat is a suspension that is given orally in conjunction with corticosteroid therapy.
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What is Givinostat used for?
Patients above the age of six who have Duchenne Muscular Dystrophy (DMD) may be treated with duvyzat (givinostat). The medication’s producer, Italfarmaco, has suggested that givinostat may also be used to treat Becker muscular dystrophy (BMD) due to the way it functions. Nevertheless, the medication is not yet authorized to treat BMD. (What is Duvyzat (Givinostat)?)
How does Givinostat work?
Givinostat is an inhibitor of HDAC. Histone deacetylases are a class of enzymes that it inhibits (HDACs). Genes that potentially decrease muscle regeneration in Duchenne are activated and deactivated by HDACs. Givinostat works to promote muscle repair, boost muscle fiber regeneration, and lessen inflammation and fibrosis by blocking HDACs.
Givinostat EMA approval status
The CHMP recommended that Duvyzat be approved by the EU on 25 April 2025 to treat Duchenne muscular dystrophy. (Read More)
When will givinostat be available in Europe?
The opinion adopted by the CHMP is an intermediate step on Duvyzat’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.
How will Givinostat be distributed in European countries?
Givinostat (Duvyzat), Italfarmaco’s medication for Duchenne muscular dystrophy (DMD), will be distributed exclusively by Medis, a top pharmaceutical commercialization business in Central and Eastern Europe, according to a statement released March 18, 2025. (Read More)
