Posted by Michael Wonder on 31 Mar 2026
FDA approves new high dose regimen of Spinraza (nusinersen) for spinal muscular atrophy
30 March 2026 - The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the high dose regimen of Spinraza in treatment-naïve and previously treated Spinraza patients.
Biogen today announced that the high dose regimen of Spinraza (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the US FDA for the treatment of spinal muscular atrophy.
