Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial
A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages and SMA types, revealed that infants receiving the elevated dose exhibited a significant improvement in motor function compared to a prespecified, untreated control group from the ENDEAR study. The investigational regimen involved a faster loading phase with two 50 mg doses given 14 days apart, followed by a higher maintenance dose of 28 mg every four months, ...