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# FDA Will Review Biogen Spinraza sNDA
- URL: https://www.fdaweb.com/fda-will-review-biogen-spinraza-snda/
- Published: 2025-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:51:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158535

FDA has accepted for review a Biogen sNDA for a higher dose regimen of Spinraza (nusinersen) for spinal muscular atrophy (SMA). A company [statement](https://investors.biogen.com/news-releases/news-release-details/fda-and-ema-accept-applications-higher-dose-regimen-nusinersen?ref=fdaweb.com) says the higher dose regimen comprises a more rapid loading regimen compared to the approved Spinraza dosing. The sNDA was based on data from the DEVOTE study that demonstrated the potential for the investigational higher dose regimen to advance the treatment of SMA, Biogen says.

Spinraza is described as an antisense oligonucleotide that targets the underlying cause of motor neuron loss by continuously increasing the amount of full-length survival motor neuron protein produced in the body.