Biogen Inc. announced the publication of results from the pivotal DEVOTE study evaluating a high-dose regimen of nusinersen in individuals with spinal muscular atrophy $(SMA)$. The results, published in Nature Medicine, demonstrated that both treatment-naïve individuals and those previously treated with the standard 12 mg dose of nusinersen experienced clinical benefits with the higher doses (50 mg and 28 mg). The study showed a more rapid reduction in neurofilament, a marker of neurodegeneration, and improvements in motor and bulbar function, respiratory health, hospitalizations, and survival. The data from the pivotal cohort (Part B) indicated statistically significant improvements in motor function among symptomatic infants treated with the high-dose regimen compared to a matched untreated group. Results were also favorable relative to the standard 12 mg regimen on key biomarker and efficacy measures.
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