Biogen’s high-dose Spinraza regimen receives European Commission approval for spinal muscular atrophy
Esme Needham | January 19, 2026 | News story | Research and Development | Biogen, Neurology, Spinraza, spinal muscular atrophy
Biogen’s Spinraza (nusinersen) has received approval from the European Commission (EC) as a new high-dose regimen for the treatment of 5q spinal muscular atrophy (SMA).
SMA is a genetic condition primarily characterised by muscle weakness that can cause problems with movement, speaking, swallowing and even breathing. 5q SMA makes up around 95% of all SMA cases.
Spinraza is already approved for the treatment of SMA patients, but the new high-dose regimen could open up new possibilities in the disease’s treatment.
The approval is based on results from the phase 2/3 DEVOTE study, as well as its ongoing extension. Infants with symptomatic SMA who had not previously received treatment showed statistically significant improvements in motor function when treated with the high-dose Spinraza regimen, compared with an untreated group from a prior study. Individuals from a wide range of age groups and SMA varieties also experienced motor function improvements after switching from a low-dose to high-dose Spinraza regimen.
The high-dose regimen was found to be well tolerated, and its safety profile was found to be consistent with Spinraza’s established profile.
“The DEVOTE results provide encouraging evidence that this new dosing option could deliver meaningful treatment outcomes with a safety profile generally consistent with the 12 mg dosing regimen,” said Eugenio Mercuri, Professor of Paediatric Neurology at the Catholic University, Rome, Italy.
Priya Singhal, executive vice president and head of development at Biogen, said: “Since its approval in the European Union in 2017, Spinraza has helped set a new standard in patient care and treated more than then 10,000 infants, children, teens and adults worldwide.”
The high-dose regimen is already approved in Japan and is currently being reviewed by the US Food and Drug Administration (FDA).
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