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# FDA OKs Higher Dose Regimen for Spinraza
- URL: https://www.fdaweb.com/fda-oks-higher-dose-regimen-for-spinraza/
- Published: 2026-03-30T12:00:00.000Z
- Updated: 2026-09-14T13:36:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160901

FDA has approved a higher-dose regimen of Biogen’s Spinraza (nusinersen) for treating spinal muscular atrophy, giving patients and clinicians a new dosing option aimed at improving outcomes in the rare neuromuscular disorder. The decision is based on data from the Phase 2/3 DEVOTE study and expands on more than a decade of clinical experience with the drug’s original 12 mg regimen, the company says.

The newly approved regimen includes higher loading and maintenance doses — two 50 mg doses administered two weeks apart for new patients, followed by 28 mg maintenance doses every four months. Patients already on the standard regimen can transition after a single high-dose loading phase, according to the company.

In the DEVOTE trial, treatment-naive infants receiving the higher-dose regimen showed statistically significant improvements in motor function compared with a matched untreated control group. The primary endpoint, measured by the CHOP-INTEND scale, demonstrated a mean improvement of more than 15 points versus a decline in the control group, according to Biogen.

Spinraza, an antisense oligonucleotide therapy delivered intrathecally, was first approved in 2016 and marked a major turning point for SMA, a genetic disease that leads to progressive muscle weakness and, in severe cases, early mortality.