In December 2023, MPs and representatives of Servier met at Westminster to discuss the supply of vorasidenib in the UK.

Some positives came out of this meeting.  The following is an exert of a report by Hugh Adams of Brain Tumour Research who attended the meeting:

"Servier confirmed that they will be sending off worldwide licencing applications including in the UK.

They will submit their application to the European Medicines Agency (EMA) early 2024 and have been granted an accelerated assessment by the EMA.

Once and if, a positive opinion from the CHMP (CHMP is the EMA’s committee responsible for human medicines) is granted in the course of 2024, Servier are then able to send off the application to the MHRA. The application to the MHRA will come under the International Recognition Procedure (IRP).

The IRP is a new procedure that allows medicinal products approved in other jurisdictions (such as Europe or the US) that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a marketing authorisation

Servier estimate that in the best case scenario, Vorasidenib could be  licenced in the UK by the end of 2024 although a further six month wait (June 2025) is a possibility depending on the level of assessment needed. 

Early Access early access to medicines scheme (EAMS):
The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need

Alternatives:
Rather than an EAMS scheme via the MHRA the alternative route for early access could be a Named Patient Programme (NPP) that provides patients and clinicians access to medicines that are not available to them in their own country where there is a high unmet clinical need.

Servier currently see this as their preferred route and although they cannot comment about the eligibility for this scheme at the moment they explained that it will be similar to the eligibility criteria that was used for the Vorasidenib clinical trial.

They are looking to open this by the end of the first quarter in 2024.

 
Siobhain McDonagh, MP, said at the end of the meeting that it was appreciated that Servier had come to Westminster and that there were positives to take away. The case remained that new therapeutics delivered hope and that for them to be unavailable to UK patients, be that due to regulatory bodies, issues with the UK market or whatever, was unacceptable and that members of the APPGBT saw it as their duty to challenge the barriers and move things forward so funding for drugs that bring hope such as Vorasidenib could be available in the UK as soon as possible”.

We have written to Servier asking for a report on progress made and are awaiting their reply. 

IN THE MEANTIME, THE PETITION IS NOW NEARING THE LANDMARK OF 10,000 SIGNATURES!  

WE WOULD LIKE TO SAY A HUGE THANK YOU FOR EVERYONE WHO HAVE SIGNED THE PETITION AND IF YOU CAN CARRY ON SHARING, IT WOULD BE MUCH APPRECIATED!

Thank you!