While nusinersen is currently administered at a dose of 12 mg intrathecally, a new treatment device with higher doses (50 mg and 28 mg) has just been authorised by the European Commission.
- This follows the results of the DEVOTE trial, which showed a significant improvement in motor function in participants with proximal spinal muscular atrophy (SMA), whether they had been treated previously or not.
- This new intrathecal treatment protocol consists of two 50 mg loading doses 14 days apart, followed by 28 mg maintenance doses every 4 months.
- In the event of a change, patients who were receiving 12 mg will receive a 50 mg dose, followed by 28 mg maintenance doses every 4 months.
The dossier must now be reviewed by the French health authorities before it can be marketed in France.
Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy. Biogen. 12 January 2026 press release.
