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. 

The latest data from the FIREFISH study of risdiplam was presented at the 14th European Paediatric Neurology Society (EPNS) Congress.

Latest risdiplam (Evrysdi) data updates, which were presented at the 2022 MDA Clinical and Scientific Conference on 13th - 16th March.

In response to our request, Biogen has shared a community update to announce that they are moving ahead with an early-stage investigation into a new treatment for SMA that could potentially treat further unmet needs.