On Friday 6 June, the European Commission issued a conditional EU marketing authorisation for givinostat (Duvyzat), a drug designed to treat Duchenne muscular dystrophy.
There is currently no cure for this rare genetic disease, characterised by progressive muscle weakness and deterioration, mainly in children.
Authorisation is based on a positive scientific assessment by the European Medicines Agency (EMA).
The EMA concluded that, although all the data is not yet available, the benefits to patients of the immediate availability of this medicine outweigh the risks. In order to confirm the efficacy of givinostat, the company has been invited to conduct two further studies based on patient data.
Conditional marketing authorisation is granted pending receipt of this additional data and is valid for one year, after which it may be renewed on an annual basis. Duvyzat comes in the form of an oral suspension to be taken as an adjunct to corticosteroid treatment.
Further details: https://aeur.eu/f/h7q (Original version in French by Lionel Changeur)