The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA.
Roche has secured approval from the US Food and Drug Administration (FDA) for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.
Roche unit Genentech has received approval from the US Food and Drug Administration (FDA) for Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in patients aged two months and above.