Market Authorisation in the EU

On Monday 12 February 2024 the European Commission announced its approval for market authorisation of Skyclarys in Europe. This was subsequent  to the positive recommendation of Skyclarys on the 15 December 2023 by the European Medicines Agency (EMA).

The European Commission’s approval of Skyclarys is a significant milestone towards expanding global access, bringing the first approved treatment to the Friedreich’s Ataxia community in the EU.

FARA Ireland is grateful to all the researchers, clinical sites, individuals with Friedreich’s Ataxia and their families, patient organizations, Biogen and

the European Medicines Agency for the research, drug development and advocacy efforts that led to this approval. We look forward to continuing our collaboration with the Friedreich’s Ataxia community with the goal of expanding access where it is needed.

It is hoped that Skyclarys can address some of the significant unmet need by bringing the first treatment to people living with Friedreich’s ataxia in Ireland.

However, it is important to understand that European regulatory approval does not mean that patients can be prescribed a medicine and that the HSE will fund it. The HSE is the decision-making body which determines whether a medicine is both clinically and cost-effective for patients.

For more details please sign up for the advocacy campaign at the link below:

Positive News Regarding Skyclarys® Approval in the EU

Like many of you, we have been closely following the developments in the approval of Skyclary’s in Friedreich’s ataxia (FA). We were very excited to see that the FDA approved Skyclary’s for the treatment of adults with FA in the US on 28th February 2023.

Whilst this is an amazing step forward, we are obviously keen for people with FA to potentially get access to the drug in the Ireland too. 

Reata pharmaceuticals (now owned by Biogen), who developed Skyclary’s, submitted an application to the regulatory agency in Europe (the EMA) at the end of 2022.

On 15 December 2023 we got some great news, this was from the European Medical Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the regulatory body that makes recommendations on drug approvals in the EU. The CHMP has recommended a market authorization for Skyclarys® for people (16 and older) with FA in the EU.  

The final decision will need to be made by the European Commission, in the first quarter of 2024. However, this was a significant hurdle to overcome.

In order for Skyclarys® to be approved in the Ireland, the EMA approval now has to signed off by European Commission which normally takes 67 days. Once this is done Biogen Ireland must make a rapid review to the Irish regulator. This usually takes about 4 weeks but due to the cost of the drug it is assumed the rapid review will be denied. Biogen Ireland would then need go through the ‘Health technology assessment’ process, where decisions are made on funding of the drug. 

FARA Ireland is working with Biogen and doing all we can to ensure access to Skyclarys® for people with FA in the Ireland as soon as possible. As part of this Process information is needed to help people get access to the drug if it is approved. We will continue to work with Biogen and will keep you updated with progress. 

See Biogen’s press release at the link below:

Call for Action

To support the advocate(s) please complete the google form below on the link below:


  1. To find out the exact number of people with FA in Ireland.
  2. To assist with getting drugs approved and funded in Ireland.

Background to Advocacy Campaign

On the 28 February 2023 the Food and Drug Administration (FDA) in USA approved SKYCLARYS (Omaveloxolone, ‘Omav’ for short) for those over 16 years of age with FA. This is the first treatment ever approved for people with FA.

In Ireland, ‘Omav’ will first need to be approved by the European Medicines Agency (EMA), which is based in Amsterdam before the Irish agency, Health Products Regulatory Authority (HPRA), will review it. Assuming, the EMA and HPRA approve ‘Omav’ for use in FA and given that the price of ‘Omav’ is $370,000 per person per year, it will then be necessary to apply to the Health Service Executive (HSE) to fund the drug.

Creating a Friedreich’s Ataxia (FA) Database in Ireland 

Currently in Ireland, it is not clear how many people have FA. The coding system that is currently used in Irish hospitals does not have a specific code for FA. Therefore, we need to find out the exact number of people in Ireland with FA to help with drug approval specifically for:

  1. Reata (Drug company producing ‘OMAV’) 
  2. For the drug to be approved in Ireland Reata must apply to the Irish Authorities. This application takes time and costs money for Reata. As we are a small country, we need to show them the amount of potential FAer’s in need of the drug. An estimate is not strong enough reason we need concrete numbers so Reata can see potential customers. 
  • Health Service Executive (HSE) 
  • The drug is currently $370,000 per person per year. At this price, a cost versus benefit analysis [also known as a Health Technology Assessment (HTA)] will need to be done by the HSE.
  • The more FAer’s we can prove in Ireland the more ethical responsibility on the government to provide funding for the drug for FAer’s to have the same human rights as non-FAer’s. 
  • The HSE also need to know their potential financial exposure which is only possible if we have an exact number of people with FA in Ireland.

Become an Advocate for FA in Ireland 

Together we are stronger. If the FA community are not all together, we could send mixed messages to Reata and the HSE, etc. Therefore, it is crucial that we work together and have one voice. I am proposing myself, Brona Kearney, as an advocate now. In time I hope other FAer’s/family members, etc. will volunteer and assist in this work. I would hope the advocate(s) will:

  • Ask the FA community their thoughts, opinions, and get feedback from them.
  • Be a representative for FAer’s. 
  • Give the FA community updates on the drug approval process. 
  • Ask for help or advice from the FA community when needed.
  • Get the FA community to assist with a petition (if necessary).

About Brona Kearney – Current FA Patient Advocate 

I’m in my early 30’s, I was diagnosed with scoliosis at 9 years and FA at 10 years. I live in Dunlavin, Co Wicklow in the family home with my parents. I have an older brother and sister. My sister also has FA. I did Accounting in College and since then I have completed professional qualifications in accounting and tax.

Currently, I am a Civil Servant, working 4 days a week from home.  I take a Wednesday off to rest, mid-week.  When I’m not working, I take the opportunity to exercise i.e. horse riding, riding my trike (three wheel bike), physiotherapy exercises, e.g. walking in posterior walker using ankle foot orthosis (AFO), hydrotherapy and floor exercise.  I use a manual wheelchair, predominately to get around. I have a car and I use hand controls to drive it.

I became an advocate for FA because I want to help others with FA and I feel I have something to offer on the topic. Something, I live by, is ‘if it feels like it’s the right thing to do, just go and do it’. Being an advocate for FA in Ireland feels right for me now and I hope we can all help one another.

Contact the advocate(s) at


The first treatment for Friedreichs Ataxia it has been approved in the US

The video below explains a little bit about this new drug. It was produced by FARA