TGA list SKYCLARYS on the Australian Register of Therapeutic Goods

The Australian Register of Therapeutic Goods (ARTG) is the public database of therapeutic goods that can be legally supplied in Australia. 

The exciting news of the approval of SKYCLARYS (omaveloxolone) is one significant step forward in the multi-stage government process to make the first treatment for Australians living with Friedreich Ataxia available and accessible.

Although the question of reimbursement is not resolved, in an earlier statement, Biogen have committed to continue engaging with the PBAC and the Department of Health and Aged Care to find a way forward.

Please be aware that widespread media engagement is planned for the week of 14 July, featuring stories from some of fara’s ambassadors, to use this announcement to draw attention to FA.