Biogen's Nusinersen Shows Efficacy Compared to Sham Treatment at Experimental Higher Dose
Biogen's nusinersen (Spinraza) showed efficacy at a higher dose than the FDA-approved regimen in the DEVOTE trial, with significant improvements on the CHOP-INTEND scale compared to a sham treatment. The higher dose was generally well-tolerated, though more serious adverse events were observed. Biogen plans to share detailed results with the SMA community and health authorities.
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Biogen's Phase II/III trial of an enhanced Spinraza dosage regimen for SMA infants showed significant motor function improvements, potentially leading to regulatory approval and reshaping treatment frameworks.
Higher dose nusinersen (Spinraza) met primary end point in phase 2/3 DEVOTE study, showing significant motor function improvement in treatment-naïve SMA infants compared to sham control from ENDEAR study. The higher dose regimen, 2 separate 50-mg doses followed by 28-mg every 4 months, outperformed the approved 12-mg regimen on key measures and was generally well-tolerated.
Biogen's DEVOTE study showed significant motor function improvements in infants with SMA using a higher dose regimen of nusinersen, prompting plans for regulatory approval.
Topline data from the DEVOTE study's Part B cohort showed that a higher dose of nusinersen met the primary endpoint of significant motor function improvement in treatment-naïve infants with SMA. The higher dose regimen, consisting of 50-mg doses followed by 28 mg every 4 months, demonstrated significant CHOP-INTEND score improvement compared to the approved 12-mg regimen. The higher dose was generally well-tolerated, with lower serious adverse events reported. Biogen plans to present further details at upcoming medical conferences.
A higher dose of Biogen’s SMA drug Spinraza met primary endpoint in infants, showing significant motor function improvement. The higher dose regimen includes faster loading and maintenance phases, with generally well-tolerated adverse events. Biogen plans to seek regulatory approval for this dose.
Biogen's nusinersen (Spinraza) showed efficacy at a higher dose than the FDA-approved regimen in the DEVOTE trial, with significant improvements on the CHOP-INTEND scale compared to a sham treatment. The higher dose was generally well-tolerated, though more serious adverse events were observed. Biogen plans to share detailed results with the SMA community and health authorities.
A higher dose of Biogen’s SMA drug Spinraza met primary endpoint in infants, showing significant motor function improvement. The higher dose regimen includes faster loading and higher maintenance doses, well-tolerated with fewer adverse events. Biogen plans to seek regulatory approval for this dose.