Europe clears Biogen’s high-dose Spinraza regimen

US biotech Biogen (Nasdaq: BIIB) said the European Commission on January 12, 2026 granted marketing authorization for a higher-dose regimen of Spinraza (nusinersen) to treat 5q spinal muscular atrophy. The EU label has been updated to include the dosing option.

The company said the approval was supported by the Phase II/III DEVOTE study and an ongoing long-term extension, with statistically significant improvements reported. Biogen also cited motor function gains in patients who transitioned from the 12mg regimen.

Safety looked broadly in line with what clinicians expect, Biogen said. The higher-dose Spinraza regimen is already approved in Japan and is under review in the USA, with a decision expected by April 3, 2026.