Biogen results from Part B, Part C Phase 2/3 DEVOTE study

Biogen announced detailed results from Part B and Part C of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of an investigational higher dose regimen of nusinersen in spinal muscular atrophy, SMA, showing benefits in both individuals previously treated and treatment-naive to nusinersen with infantile-onset or later-onset SMA. The investigational, higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen. Data to be presented during the World Muscle Society, WMS, 2024 Congress highlight the potential of this investigational higher dose regimen to help address remaining unmet need in SMA. Biogen plans to file applications for the 50/28 mg higher dose nusinersen regimen with global regulatory agencies. Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg.