CFI has just been informed by the European Medicines Agency (EMA) that the innovative and ground breaking drug Kaftrio has been approved by the European Commission. This is great news for Ireland, North and South.

The decision in effect grants marketing authorisation for Kaftrio for the European Union. This means that Vertex can now proceed with the next steps for commercialisation in Europe.

The extent of the license granted to Vertex is not yet been published but further information should be available shortly. CFI understands that a very broad license has been granted to Vertex that covers over 900 gene mutations (also called gene alterations). CFI expects a full list will be available within the coming days- they are not available at present.  

Please be advised that there will be a number of weeks before Kaftrio is dispensed in Ireland (dates to be confirmed)

CFI's best estimate remains October 2020 but we are living in uncertain times and this may change.

To read the press release from Vertex click here