- The results of Parts B and C of the DEVOTE study confirm the clinical benefit of higher doses of nusinersen (50/28 mg) in both previously treated and untreated nusinersen patients.
- The dosage regimen tested also shows faster slowing of neurodegeneration, as measured by neurofilament levels.
- Biogen plans to file registration applications for approval of higher doses of nusinersen worldwide
Biogen announced detailed results from Parts B and C of the Phase 2/3 DEVOTE study, evaluating the safety and efficacy of an investigational regimen of higher doses of nusinersen in spinal muscular atrophy (SMA), showing benefit in both previously treated and untreated nusinersen patients with SMA with onset in infancy or later.
The investigational higher dosing regimen of nusinersen involves faster saturation doses (two 50 mg doses 14 days apart) and higher maintenance doses (28 mg every 4 months) compared to the approved nusinersen dosing regimen. The data underscore the potential of this investigational treatment regimen at higher doses to address unmet needs for SMA treatment.
"What's striking is that the higher dosing ...
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