Nature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy
View original at globenewswire.comNature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy Findings from DEVOTE support clinical benefits of the high-dose regimen of nusinersen (50 mg and 28 mg) in both treatment-naïve individuals and those previously treated with 12 mg nusinersenThe…
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One of the most notable changes seen with the higher dose regimen was a more rapid reduction in neurofilament, a marker of neurodegeneration
80% confidencePublication of the DEVOTE results in Nature Medicine further validate the importance of these data and the future role that the high dose regimen will play in improving outcomes for people living with SMA
80% confidenceResults favored the high-dose regimen relative to sham across secondary endpoints and trended in favor of the high-dose regimen over the currently approved 12mg regimen on key biomarker and efficacy measures
80% confidenceThe publication of the DEVOTE data are an important step in commitment to bring the high dose regimen of nusinersen to people living with SMA as quickly as possible
80% confidenceTreatment with the high-dose regimen led to improvement across important domains like motor and bulbar function, respiratory health and hospitalizations, and survival
80% confidenceTreatment-naïve, symptomatic infants who received the high-dose regimen experienced statistically significant improvements in motor function as measured by CHOP-INTEND compared to matched sham group
80% confidenceThe safety profile of the high-dose regimen of nusinersen was broadly consistent with the known safety profile of the 12 mg regimen
80% confidence