Biogen Confirm Plans for Australian SKYCLARYS®

First Therapy to Treat Friedreich Ataxia

You will be aware that we have been in regular communication with Biogen since their acquisition of the Reata Pharmaceuticals FA treatment SKYCLARYS® .

We are delighted to be able to advise that Biogen Australia has confirmed that they plan to make regulatory and reimbursement submissions this year and will keep us updated as and when information is made available. They hope we are reassured by the progress already made in the USA and Europe and have their commitment to move as quickly as processes allow in Australia.

This follows the news earlier this week that the European Commission has authorised SKYCLARYS® for the treatment of Friedreich Ataxia in adults and adolescents aged 16 years and older within their jurisdiction.

The Regulatory & Reimbursement process in Australia is a multi-stage undertaking.

Should an indication of acceptance by the Therapeutic Goods Administration be received by Biogen, the next critical phase becomes Pharmaceutical Benefits Advisory Committee review.

Our top priority now at fara is to share guidance and the actions our community can take to demonstrate the significant need for SKYCLARYS® in Australia to help drive successful approval and access.