MDSpire - Takeaway
FDA & Government News

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.

Share

  • 1

    FDA has approved a high-dose nusinersen regimen for SMA.

  • 2

    New dosing: two 50 mg loading doses, then 28 mg every 4 months.

  • 3

    Clinical data supports motor function improvement.

  • 4

    Most common side effects: pneumonia and malnutrition.

  • 5

    Monitoring for bleeding and kidney issues is advised.

  • 6

    Dosage transition options for existing patients are available.

  • 7

    Nusinersen is delivered via intrathecal injection.

Original Source(s)

FDA Updates SMA Treatment Dosing

  • by Kathryn Wighton

  • March 30, 2026

Related Content

Progesterone Linked to Brain Structure Changes

MRI study finds stronger associations than estradiol across menstrual phases

Reducing Constipation in Parkinson’s, Step by Step

A 3-month walking program was associated with improved constipation symptoms and lower Parkinson’s disease severity scores in a small uncontrolled pre–post study

Zack Z. Ramilevich, M.D., Joins Marcus Neuroscience Institute as a General Neurologist

Board-certified neurologist Zack Z. Ramilevich, M.D., has joined Marcus Neuroscience Institute, part of Baptist Health, as a general neurologist.

  • by

  • March 26, 2026

  • 2 min