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FDA Updates SMA Treatment Dosing

A higher-dose nusinersen regimen for spinal muscular atrophy demonstrated statistically significant motor function improvement in treatment-naïve infants in the DEVOTE trial with a safety profile consistent with prior dosing.

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The FDA has approved a higher-dose regimen of nusinersen (SPINRAZA) for spinal muscular atrophy in pediatric and adult patients, introducing a new dosing schedule with increased exposure. This regimen consists of two 50 mg loading doses followed by 28 mg maintenance doses every four months. Data from the phase 2/3 DEVOTE study showed significant improvements in motor function among treatment-naïve infants with symptomatic disease. The safety profile remains consistent with earlier doses, with monitoring for potential complications required.

Original Source(s)

FDA Updates SMA Treatment Dosing

  • by Kathryn Wighton

  • March 30, 2026

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