Omaveloxolone Granted US Food & Drug Administration Regulatory Approval
This morning (Australian Time) Friedreich Ataxia treatment SKYCLARYS (Omaveloxolone) from Reata Pharmaceuticals was granted US Food & Drug Administration (FDA) regulatory approval. Commercial manufacturing and distribution can now take place in the United States.
Click to Read Reata's Market Release
What this means for Australia
Whilst Omaveloxolone (Omav) has been grated FDA approval in the United States, as with all pharmaceuticals, this does not extend to approval for distribution and sale of Omav in Australia. This requires approval by the Australian Therapeutic Goods Administration (TGA).
fara Australia have been in ongoing discussions with Reata throughout 2022 and this year pressing them to prioritise seeking TGA approval and commence strategic planning for Pharmaceutical Benefits Scheme review and approval for prescription to Australians with Friedreich Ataxia.
This included a face-to-face meeting in Dallas during ICAR 2022 with key Reata stakeholders. We have worked closely with FARA US and Professor Martin Delatycki of the Murdoch Children’s Research Institute in these discussions.
As a part of pursuing the availability of Omav in Australia, fara have facilitated introductions to local third-party consultants capable of supporting Reata to navigate the Australian TGA and PBS processes.
To date Reata have made no specific commitment to time frames for marketing of Omav in Australia. Their stated priority is to first achieve their US FDA approval, prior to turning their attention to other global markets.
Whilst we are disappointed by this approach, we are excited that this first milestone has now been achieved.
We are also encouraged that Reata have acknowledged to us that the involvement of the Australian FA patient community in Clinical Trials for Omav, is of significance and importance. fara Australia will continue to work with other key players in pressing for Australia to be high on Reata’s list of global market priorities.
As news comes to hand, we will update you on our progress..