Today the MHRA have approved the licence for Risdiplam.
What does this mean for the EAMS?
Following MHRA guidelines, the Early Access to Medicines Scheme (EAMS) for risdiplam is now closed in Great Britain for new patients (i.e. patients identified after marketing authorisation). However Roche have agreed with the MHRA that, for patients already identified at the time of Great Britain marketing authorisation, applications for these patients can be accepted after marketing authorisation up to and including 1 July 2021. These previously identified patients – should they fulfil the EAMS eligibility criteria – are therefore still able to receive risdiplam through the EAMS. Existing patients participating in the EAMS will continue to be treated under the terms of the EAMS.
We are currently seeking more clarity over the application process for EAMS and will keep you all updated.