Community update from Roche
We are pleased to share the latest community update from Roche, announcing that the CHMP (Committee for Medicinal Products for Human Use) at the European Medicines Agency (EMA) has recommended the approval of an indication extension for risdiplam (Evrysdi), for all ages, from birth.
This recommendation has been referred to the European Commission for a decision on marketing approval authorisation for the label extension. If approved, Evrysdi will be available to treat people of all ages with SMA in the European Union, including babies from birth.