Posted by Michael Wonder on 18 Nov 2025
High dose regimen of nusinersen receives positive CHMP opinion for the treatment of spinal muscular atrophy
17 November 2025 - Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment naïve participants and those transitioning from the currently approved 12mg dose regimen.
Biogen today announced the CHMP of the EMA adopted a positive opinion recommending by consensus the approval of the high dose regimen of nusinersen for the treatment of 5q spinal muscular atrophy.
