Roche Evrysdi gets European Commission nod for babies under two months old with spinal muscular atrophy
Basel: Roche has announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months. Interim data from the ongoing RAINBOWFISH trial in pre-symptomatic babies from birth to six weeks with Type 1 SMA supported the marketing authorisation extension.
“The SMA community welcomes the European Commission’s decision to extend the use of Evrysdi from birth,” said Dr Nicole Gusset, President & CEO of SMA Europe. “Preserving motor neurons from the earliest age possible and preventing their irreversible loss can have a substantial impact on a person’s future ability to move and function. We look forward to continued collaborative efforts to improve diagnosis, including newborn screening, and ensuring all individuals living with SMA have access to medicines.”
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