Skyclarys approved in the EU

[wobblybee]

The EMA approves the drug Skyclarys® to treat adults with Friedreich’s ataxia in EU countries

On 12th February 2024, the European Medicines Agency (EMA) announced that they have approved the drug Skyclarys® (Omaveloxolone) for the treatment of Friedreich’s ataxia in adults in EU countries.

This approval by the EMA will not result in approval in the UK, as an application still needs to be submitted to the UK regulators (the MHRA). We believe that the approval in the EU will pave the way for faster approval in the UK. From January 1st, 2024, the new fast-track route for approval of drugs in the UK (including Northern Ireland) was launched.

This is called the International Recognition procedure and will be a fast-track for drugs that have already been approved in other countries (including by the FDA in the US and the EMA in Europe). There are two routes, taking either 60 days or 110 days.

There are various criteria in order to determine which route would be taken.

It is important to note that if the drug gets approved it then needs to be assessed for cost effectiveness by NICE to see whether it will be funded by the NHS.

Ataxia UK’s Head of Research, Julie Greenfield says: ‘We are making every effort to encourage and support Biogen in seeking UK regulatory approval. In addition, we are discussing ways to cooperate to gather useful information from people with FA in the UK. This information is needed to help people get access to the drug if it is approved’.

We will ensure the FA community in the UK is kept up to date with the latest developments as soon as possible while remaining confidential when needed. The interests of families affected by FA, and all other types of ataxias, in the UK, are and will continue to be at the forefront of all our efforts.

To read the press release from Biogen, the pharmaceutical company which has been developing Skyclarys®, to find out more about Skyclarys®, and to sign up to our dedicated newsletter, head over to: ataxia.org.uk/omav-updates/

[Adam1420]

Hi Wobblybee, thanks for posting this. Wasn't able to get clarification on this myself so very promising. Thanks!

[wobblybee in reply to Adam1420]

🙂Hopefully…it will be available asap in the UK.