Ataxia UK is delighted with today’s announcement from the EMA’s 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. See EMA website here.
In order for Skyclarys® to be approved in the UK, Biogen will need to submit an application to the UK regulator, the MHRA. We believe an approval in the EU will pave the way for a faster route to approval in the UK. It is worth noting that after drug approval, the drug would need go through the ‘Health technology assessment’ process, where decisions are made on funding of the drug within the NHS.
Ataxia UK is collaborating with Biogen and doing all we can to ensure access to Skyclarys® for people with FA in the UK. Indeed, a productive meeting was held with five members of the Biogen UK team on the 8th December at the Ataxia UK office. We understand Biogen plans to seek approval from the MHRA and to make use of the ‘fast-track approval process’ (called the International Recognition Procedure), that is due to be in place in the UK in January 2024. We will continue to work with them and will keep you updated with progress.
See Biogen’s press release here and their community statement to Ataxia UK here.
