Biogen, Ionis end of study results for SPINRAZA published.
Biogen (BIIB) and Ionis Pharmaceuticals (IONS) announced end of study results from CHERISH, the Phase 3 study evaluating SPINRAZA for the treatment of individuals with later-onset spinal muscular atrophy, were published in The New England Journal of Medicine. The full manuscript titled, "Nusinersen Versus Sham Control in Later-Onset Spinal Muscular Atrophy," appears in the February 15 issue of The New England Journal of Medicine. The pre-specified CHERISH primary endpoint was improvement in motor function, as defined by change from baseline in the Hammersmith Functional Motor Scale-Expande. The HFMSE is a validated tool specifically designed to assess motor function in individuals with SMA. The final analysis demonstrated a highly statistically significant and clinically meaningful improvement in motor function in individuals treated with SPINRAZA versus the sham control, as observed by the treatment difference of 4.9 points in the mean change from baseline to Month 15 in the HFMSE score (p=0.0000001). When measuring changes from baseline, individuals who received SPINRAZA (n=84) achieved a 3.9 point mean improvement at Month 15, while individuals who were not on treatment (n=42) experienced a mean decline of 1.0 point. Primary endpoint results of the end of study analysis were consistent with the interim analysis.
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|Date:||Feb 14, 2018|
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