Posted by Michael Wonder on 22 Jul 2023
CHMP recommends Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
21 July 2023 - Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed 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 EU CHMP has adopted a positive opinion for the extension of the Evrysdi (risdiplam) European Union marketing authorisation, which would include infants with genetically confirmed diagnosis of SMA type 1, type 2 or type 3 or with one to four SMN2 copies, including from birth to below two months.
