Skyclarys - Where it stands
Disclaimer: Please respect that these are the personal views of the patient.
Firstly a bit of background:
Omaveloxolone – commercial name Skyclarys – has been found in trials to slow the progression of Friedreich’s Ataxia in some people by up to 50%. It is produced by the American pharmacological company, Biogen. They got approval in the USA to sell it in 2023 and it was approved in Europe in 2024. In April last year it was approved here in the UK by the MHRA as being safe but required the National Institute for Health and Care Excellence (NICE) to also approve it for it to available on the NHS. The manufacturer, Biogen, withdrew its evidence submission (also April last year – same day in fact!) when they were told by NICE that they would not be taking it any further. No reason was provided by either party but it is assumed it was due to cost – estimated at £298,500 annually per patient.
How things stand now:
Currently there is an open letter being circulated by Ataxia UK to Andy Burnham PM to try and get an interim access program for the drug whilst the various official bodies sort out ongoing availability. There is also a petition that has been compiled by the FA community in the UK to ask the government to give access to the drug. It had to get 10,000 signatures to get a response from the government (which it did on 15th August) and requires 100,000 signatures by 24th September to be considered for debate. It is currently at 45,722 so still quite a way to go but we are determined to get there. Just last week the Republic of Ireland got it approved for reimbursement after pressure was put on the government there so it has made us even more hopeful and determined to do this.