Omaveloxolone Early Compassionate Access Program Now Open in Australia!
Please find copied below an exciting announcement from Professor Martin Delatycki of the Murdoch Children's Research Institute and the Monash Medical Centre's Friedreich Ataxia Clinic.
Professor Delatycki has asked that we share this news to ensure it reaches as many individuals living with FA and their families as possible.
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Dear members of the Australian Friedreich ataxia community,
Re: Early Compassionate Access Program for omaveloxolone
I am writing to you with some exciting news. Biogen has opened an early compassionate access program for omaveloxolone This means that some individuals with Friedreich ataxia will be eligible to receive omaveloxolone in the relatively near future. The early compassionate access program requires strict inclusion and exclusion criteria that means that not all individuals will be eligible to receive omaveloxolone under this program. I recognise that this will be very disappointing for those individuals and their families, however omaveloxolone is under review by the Therapeutic Goods Administration (TGA) for registration in Australia. This early compassionate access program will make omaveloxolone available to eligible people with Friedreich ataxia now, before this process is complete.
Key inclusion and exclusion criteria for the early compassionate access program are:
1. Aged 16 to 40 inclusive.
2. Citizen or permanent resident of Australia. Unfortunately, those in New Zealand are not eligible for this program.
3. Criterion based on severity of Friedreich ataxia as measured by the modified Friedreich Ataxia Rating (mFARS) scale.
4. Heart involvement [cardiomyopathy] that significantly diminishes heart pumping.
5. Particular abnormal blood test parameters.
6. People taking some medications are excluded.
7. Women who are pregnant or breastfeeding are excluded.
8. Males and females attempting to achieve a pregnancy are excluded.
It will not be possible to have all eligible people commence on the program at the same time. There are several requirements before a person can commence on omaveloxolone that includes blood tests and assessments. There are also logistical requirements to enable eligible people from all over Australia to access omaveloxolone equitably. It will take several months for all individuals to be assessed for eligibility and to commence on omaveloxolone if eligible.
If you believe you are eligible based on these criteria and would like to be considered for treatment with omaveloxolone, please email janne.pitkin@mcri.edu.au to let us know that you wish to be considered for this. Your email will be acknowledged. Please do not send further emails as people will be contacted over time for assessment.
Thank you for your patience as we implement this exciting next step.
Professor Martin Delatycki
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Omaveloxolone is the first approved treatment for Friedreich Ataxia in the world. It is currently available in the United States and some EU countries marketed as Skyclarys). Omaveloxolone is currently under review by the Australian Therapeutic Goods Administration and the Pharmaceutical Benefits Advisory Committee.