Like many of you, we have been closely following the developments in the approval of Skyclarys® for the treatment of Friedrich’s ataxia. We were very excited to see that the EMA approved Skyclarys® for the treatment of adults with FA in Europe on 12th February 2024.
This does not automatically mean approval of the treatment in Ireland.
For Skyclarys® to be approved in Ireland Biogen Ireland must make a rapid review to the Irish regulator. This usually takes about 4 weeks but due to the cost of the drug, it is assumed the rapid review will be denied. Biogen Ireland would then need to go through the Health Technology Assessment process, where decisions are made on funding the drug.
Further information on Biogen is available at.
