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:

https://investors.biogen.com/news-releases/news-release-details/chmp-issues-positive-opinion-biogens-skyclarysr-omaveloxolone