The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in people 2 months and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 with one to four SMN2 copies.
Now that Evrysdi (risdiplam) has been given a positive opinion by the CHMP, the decision must be authorised by the European Commission. It is expected that this will be done in the next two months.
What does this mean for the UK?
As the UK left the European Union during the ongoing EMA assessment of risdiplam, Roche will submit risdiplam for marketing authorisation consideration by the Medicines and Healthcare products Regulatory Agency (MHRA) under the European Commission Decision reliance procedure in the coming weeks. The EMA marketing authorisation date will apply to Northern Ireland only.
The National Institute of Health and Care Excellence (NICE) appraisal of Risdiplam is underway and the Committee will meet in May.
Risdiplam will be submitted to the Scottish Medicines Consortium (SMC) in the first half of 2021.
What does this mean for the Early Access to Medicines Scheme (EAMS)?
Once Great Britain marketing authorisation is received, the Early Access to Medicines Scheme (EAMS) will close for new patients (i.e. patients identified as eligible for risdiplam after Great Britain marketing authorisation) in line with the MHRA process. Patients enrolled in EAMS before Great Britain marketing authorisation will continue to receive supply of treatment.
Patients enrolled in EAMS in Northern Ireland before marketing authorisation will continue to receive supply of treatment.
Find out more information in Roche’s press release
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