Posted by Michael Wonder on 30 Aug 2023
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months’ treatment.
Roche announced today that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union marketing authorisation to include infants with a clinical diagnosis of spinal muscular atrophy Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months.
