Givinostat has already received regulatory approval in the US and UK, with an evaluation ongoing by the European Medicines Agency (EMA). DMD patients in Europe and Turkiye await EMA approval of Givinostat (Duvyzat).
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 are still wondering when givinostat for DMD will be approved in their countries as well.
Here is all the information patients in Europe and Turkiye need to know about the EMA approval timelines for Givinostat. containing information on how to get the treatment before it becomes accessible in your nation.
Table of Contents
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 EMA has been considering Duvyzat’s application for marketing authorization since August 2023. With the exception of any breaks for requesting more information from the manufacturer, a review usually takes up to 210 days. The application for givinostat should be decided by the second half of 2025, based on this typical timeframe. But we’ll have to wait and see if it occurs. (UK Approves Givinostat (Duvyzat))
When will givinostat be available in Europe?
Regretfully, the Givinostat will not be instantly accessible throughout the EU, even if it receives EMA clearance by the middle of 2025. Each member state has a very different time frame from EMA approval to market launch. With an EU average of 636 days, the average time to launch for orphan medications, like Givinostat, varies from 102 days in Germany to 1,081 days in Estonia.
In Turkiye, the time from central approval to usability is stated as 1008 days.(EFPIA Patients W.A.I.T. Indicator 2021 Survey)
In other words, while Givinostat may be accessible in some EU nations by 2025, most patients would have to wait at least a year for the medication to be sold in their countries.
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)
