Current status: Answered by Jenni Minto on 21 March 2025
To ask the Scottish Government, in light of it being approved by the Medicines and Healthcare Products Regulatory Agency for the rest of the UK, for what reason the medication, Givinostat, for people with Duchenne muscular dystrophy, is not available through NHS Scotland.
A conditional marketing authorisation was granted by the Medicines and Healthcare products Regulatory Agency for givinostat (Duvyzat®) on 20 December 2024. A conditional marketing authorisation is an early temporary licence.
The pharmaceutical company that markets Duvyzat® has offered a national Early Access Programme which provides free of charge access to the medicine for the treatment of ambulant young people aged six years and older with Duchenne muscular dystrophy. This has been in place since late December 2024.
It is for individual Health Boards to consider the implementation of any new medicine, and ultimately for the clinician in charge of a person’s care to advise on suitable treatment options. The Scottish Government is aware that Health Boards are currently considering how to schedule offering this medicine in the most fair and equitable manner.