Today, the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). This means that risdiplam is now approved in the US to treat SMA in children and adults of all ages.
Following our request for regular updates, Roche has shared an overview of their work in the community over the past year and a summary of progress in advancing research and increasing access to risdiplam in Europe and beyond.
The Summary of Product Characteristics (SmPC) for Zolgensma has been updated.
Following our request for regular updates, Roche is delighted to inform us that today the European Commission (EC) approved Evrysdi™ (risdiplam), the first and only at home treatment for SMA, with proven efficacy in adults, children and babies two months and older.