Sydney, Australia – 21st July 2025 – Biogen Australia welcomes the TGA (Therapeutic Goods Administration) approval of SKYCLARYS™ (omaveloxolone) as the first treatment for adults and adolescents aged 16 years and older with the rare, genetic, progressive disease Friedreich ataxia (FA).
SKYCLARYS is not listed on the Pharmaceutical Benefits Scheme (PBS).
First treatment option SKYCLARYS™ (omaveloxolone) for Australians diagnosed with ‘neurogenerative disease’ Friedreich ataxia1